Circular bone tunneling device employing a stabilizing element

ABSTRACT

The present invention provides a circular bone tunneling device, comprising: a hollow elongate body comprising a hollow elongate body head, said hollow elongate body head defining a rigid circular arc, comprising a surgical needle; an extendable and retractable support element, reconfigurable from an extended configuration to a retracted configuration; said support element, in said extended configuration, adapted to be located along said path formed by said rigid circular arc; said support element and said hollow elongate body head are adapted to grasp said bone from at least two points along the circumference of said bone; a stabilizing element.

REFERENCE TO RELATED APPLICATIONS

The present application is a continuation application of U.S. patentapplication Ser. No. 14/240,082, filed Apr. 9, 2014, entitled CIRCULARBONE TUNNELING DEVICE EMPLOYING A STABILIZING ELEMENT, now U.S. Pat. No.9,820,754, which is a National Phase application of International PatentApplication No. PCT/IL2012/000319, filed Aug. 23, 2012, entitled“CIRCULAR BONE TUNNELING DEVICE EMPLOYING A STABILIZING ELEMENT”, whichclaims priority from U.S. Provisional Application No. 61/526,717, filedAug. 24, 2011, U.S. Provisional Application No. 61/584,267, filed Jan.8, 2012 and U.S. Provisional Application No. 61/636,751, filed Apr. 23,2012, the disclosures of which are hereby incorporated by reference.

FIELD OF THE INVENTION

This invention generally relates to a bone tunneling device and anadjustable suture passer for use in arthroscopic surgery. Specifically,it relates to suture passers that are capable of passing a suture bytransosseous technique through a bone directly without need for drillingthrough the bone.

The present invention provides an adjustable suture passer, adapted tocreate a transosseous tunnel and enable passage of a suture through abone while grasping the circumference of the same.

In other words the present invention provides a bone tunneling devicethat partially encompasses and firmly holds the bone at two differentcontact points along an arc and is further stabilized by a stabilizingelement that reduces the movement (degrees of freedom) of the device byfixating the device to the bone at a third contact point such thatmovement is minimized preventing rotation around the first two contactpoints. The additional fixation point can prevent inadvertent movementby the physician due to minor hand movements during surgical procedures.

BACKGROUND OF THE INVENTION

Reattachment of a ligament to a bone in arthroscopic procedures such as,for example, repair of a torn rotator cuff typically involves two steps.First, an anchor is inserted into the bone. Then, the ligament isattached to the bone by passing a suture through the ligament tissue andthen through the anchor, thereby tying the ligament to the bone.

There are several drawbacks to this method. First, two separate actionsmust be performed in order to attach the ligament to the bone, namely,insertion of the anchor into the bone and suturing of the ligament. Thenecessary involvement of at least two separate sets of tools inherentlycomplicates the surgical procedure, when compared to performing theprocedure while using a single tool.

In addition, placement of the anchor may require drilling into the bone,which creates debris that must be removed and can increase the stress onthe bone. The procedures described above often require large accessports and/or open surgery to enable the positioning and actuation of therequired tools.

Methods that do not require an anchor generally require creation of aplurality of bores in the bone. U.S. Pat. No. 6,523,417 discloses amethod for suturing soft tissue to a bone in which a hole is drilledinto the bone and a slit cut into it. PCT Pat. Application WO09/107121discloses a method of suturing soft tissue to a bone in which two boresare made in the bone at an angle, preferably 70°. PCT Pat. ApplicationsWO10/056785, WO10/056786, and WO10/056787 disclose suture anchoringsystems in which two orthogonal bores are made in the bone. A majordisadvantage of these methods is that the presence of a plurality ofbores at an angle significantly weakens the bone, increasing thelikelihood of later injury, fractures and eventually weakening of thebone. The main disadvantage in said publication is that these methodsrequire highly invasive surgery in order to allow access and actuationof tools used in the procedure.

U.S. Pat. No. 6,328,744 discloses a bone suturing device in which aneedle enters a bone at a non-perpendicular angle and a curved path dueto the force exerted on the needle by a hinged handle. In preferredembodiments of the invention, a second needle is used as well and thebore created from two sides. While the purpose of the second needle isto increase the pressure used by the first needle to enter the bonerather than to push the bone away, the amount of stabilization actuallyperformed by the second needle is limited because the two needles enterthe bone from the same side. Thus. It is a long felt need to provide adevice which will enable stable fixation of the needle tunneling deviceto the targeted bone surface in order to create an arched transosseoustunnel without drilling in a minimally invasive surgical procedure.

There is thus a long-felt need for a device that supports the bone froma side other than that through which the needle enters and can enabledirect attachment of the ligament and the bone by passing the suturethrough the bone without any need for a separate anchor or for drillingholes such as two orthogonal holes in the bone.

Yet more, it is a further long-felt need for a transosseous tunnelingdevice that is adapted to pass a suture through transosseous tunnel soas to provide said attachment of ligament to the bone.

Yet more, it is a further long felt need to provide a tool that can beapplied to the bone surface through a small minimally invasive incisionand then be converted into a second larger profile that enables fixationto a bone surface along the path of an arc within the bone withoutenlargement of the access incision point.

SUMMARY OF THE INVENTION

It is therefore one object to provide a circular bone tunneling devicefor use in arthroscopic surgery, comprising: a hollow elongate bodycomprising a hollow elongate body head, said a hollow elongate body headdefining a rigid circular arc; said hollow elongate body head comprisinga surgical needle adapted to tunnel through a bone along a path formedby said rigid circular arc; and, an extendable and retractable supportelement, reconfigurable from at least one extended configuration to atleast one retracted configuration; said support element, in saidextended configuration is adapted to be located along said path formedby said rigid circular arc; said support element, in said extendedconfiguration, and said hollow elongate body head are adapted to graspsaid bone from at least two points along the circumference of said bone;a stabilizing element reconfigurable from at least one extendedconfiguration to at least one retracted configuration; wherein saidstabilizing element in said extended configuration is adapted to be inphysical contact with said bone so as to reversibly fixate theorientation of said circular bone tunneling device relative to saidbone.

It is another object of the present invention to provide the circularbone tunneling device as defined above, wherein said stabilizing elementis adapted to reciprocally move along the main longitudinal axis of saidcircular bone tunneling device so as to be reconfigured from saidextended configuration to said retracted configuration and vice versa.

It is another object of the present invention to provide the circularbone tunneling device as defined above, wherein said stabilizing elementis pivotally coupled, at a pivot point, to the distal end of said hollowelongate body at a pivot point of said circular bone tunneling device.

It is another object of the present invention to provide the circularbone tunneling device as defined above, wherein said stabilizing elementis adapted to radially and pivotably rotate around said pivot point soas to be reconfigured from said extended configuration to said retractedconfiguration and vice versa.

It is another object of the present invention to provide the circularbone tunneling device as defined above, wherein said stabilizing elementin said extended configuration is adapted to be reversibly anchoredwithin said bone.

It is another object of the present invention to provide the circularbone tunneling device as defined above, wherein said stabilizing elementcomprises a distal end and a proximal end; said distal end comprises aflange and a tip; said tip is adapted to penetrate said bone and toreversibly anchor said stabilizing element within the same.

It is another object of the present invention to provide the circularbone tunneling device as defined above, said flange is adapted to limitthe insertion of said distal end of said stabilizing element into saidbone such that only said tip is anchored within said bone.

It is another object of the present invention to provide the circularbone tunneling device as defined above, wherein the shape of said tip ofsaid stabilizing element is selected from a group consisting ofnail-like tip, screw-like tip and any combination thereof.

It is another object of the present invention to provide the circularbone tunneling device as defined above, wherein said stabilizing elementcomprises at least one marker, adapted to indicate to the user as forsaid stabilizing element position with respect to the bone.

It is another object of the present invention to provide the circularbone tunneling device as defined above, wherein said device furthercomprises an indicator said indicator is provided with a yardstickhaving numerical references on the same; said numerical references areadapted to indicate to the user the depth of penetration of saidstabilizing element into said the bone.

It is another object of the present invention to provide the circularbone tunneling device as defined above, additionally comprising alocking mechanism adapted to lock said stabilizing element in thedesired position.

It is another object of the present invention to provide the circularbone tunneling device as defined above, additionally comprising at leastone suture cartridge comprising a suture; said suture is adapted to bepassed through said circular transosseous tunnel previously tunneledthrough said bone.

It is another object of the present invention to provide the circularbone tunneling device as defined above, wherein said suture cartridgecomprising an external scaffold enclosing an inner body throughout whicha surgical tool is inserted.

It is another object of the present invention to provide the circularbone tunneling device as defined above, wherein said inner body ischaracterized by having diameter of at least 3 mm.

It is another object of the present invention to provide the circularbone tunneling device as defined above, wherein said surgical tool isselected from a group consisting of grasper, tendon holder, scissors,diathermy, scalpel, stapler, jig, suturing means, said stabilizingelement and any combination thereof.

It is another object of the present invention to provide the circularbone tunneling device as defined above, further comprising a shaft,parallel to said device's main longitudinal axis; wherein said hollowelongate body head located at the distal end of said shaft and definingsaid rigid circular arc with the concave side of said arc forming saidunderside of said hollow elongate body head.

It is another object of the present invention to provide the circularbone tunneling device as defined above, wherein said shaft additionallycomprising an inner elongated hollow tube throughout which a surgicaltool is inserted.

It is another object of the present invention to provide the circularbone tunneling device as defined above, wherein said inner elongatedhollow tube is characterized by having diameter of at least 3 mm.

It is another object of the present invention to provide the circularbone tunneling device as defined above, wherein said suture cartridge iscoupled to said shaft and adapted to reciprocally move along the mainlongitudinal axis of the same.

It is another object of the present invention to provide the circularbone tunneling device as defined above, wherein said support elementcomprises at least one hook adapted to encase said suture.

It is another object of the present invention to provide the circularbone tunneling device as defined above, wherein said movement of saidsuture cartridge in the direction of said support element loads saidsuture onto said hook of said support element.

It is another object of the present invention to provide the circularbone tunneling device as defined above, wherein said surgical needle isa rigid surgical needle.

It is another object of the present invention to provide the circularbone tunneling device as defined above, wherein said surgical needle iseither straight or curved and shaped as circular arc.

It is another object of the present invention to provide the circularbone tunneling device as defined above, wherein said needle is adaptedto engage with said support element once said needle has tunneledthrough and exited said bone along said arced path.

It is another object of the present invention to provide the circularbone tunneling device as defined above, wherein said needle comprisescatching means adapted to catch and encase said suture once said needleengages with said support member.

It is another object of the present invention to provide the circularbone tunneling device as defined above, wherein said catching means areselected from a group consisting of mechanical means, magnetically,electrical means or any combination thereof.

It is another object of the present invention to provide the circularbone tunneling device as defined above, wherein said mechanical meansare at least one hook adapted to encase said suture once said needleengages with said support member.

It is another object of the present invention to provide the circularbone tunneling device as defined above, wherein said needle comprises atleast one hook adapted to encase said suture once said needle engageswith said support member.

It is another object of the present invention to provide the circularbone tunneling device as defined above, wherein said extendable andretractable support element (54) is attached to the distal end of saidshaft and structured and configured such that when said support elementis extended, it opposes the underside of said curved hollow elongatebody head and its distal end is located along the path formed by saidrigid circular arc.

It is another object of the present invention to provide the circularbone tunneling device as defined above, wherein said hollow elongatebody head comprising an arc-like shaft along which said support memberis guided along tracks so as to be reconfigured to said extendedconfiguration.

It is another object of the present invention to provide the circularbone tunneling device as defined above, additionally comprising asupport element driving mechanism, adapted, upon activation of a supportelement control, to drive the motion of said support element.

It is another object of the present invention to provide the circularbone tunneling device as defined above, wherein upon activation of saidsupport element, the same is extended, such that said bone is beinggrasped by and between said extendable and retractable support elementand said head.

It is another object of the present invention to provide the circularbone tunneling device as defined above, wherein the distal end of saidhollow elongate body head comprises an orifice through which a rigidcircular hollow tube passes through.

It is another object of the present invention to provide the circularbone tunneling device as defined above, wherein the extendable andretractable support element is adapted to reach, upon various degrees ofextension, predetermined locations relative to the distal end of saidrigid circular hollow tube, such that the distance between said distalend of said rigid circular hollow tube and the upper side of saidsupport element provides a slip fit over a bone through which a sutureis to be passed.

It is another object of the present invention to provide the circularbone tunneling device as defined above, additionally comprising a handle(12).

It is another object of the present invention to provide the circularbone tunneling device as defined above, wherein said handle is either areusable handle or a single use handle.

It is another object of the present invention to provide the circularbone tunneling device as defined above, wherein said arthroscopicsurgery is performed without the need of drilling through said bone.

It is another object of the present invention to provide the circularbone tunneling device as defined above, wherein said hollow elongatebody comprises: at least one track (522) disposed within said hollowelongate body; a connecting wire (132) forming a loop within said hollowelongate body, the proximal end of said loop physically connected tosaid rigid circular hollow tube control mechanism; a distal slidablemember (4) disposed within said track and adapted to slide within saidtrack while maintaining said needle and one leg of said loop formed bysaid connecting wire to pass through said hollow elongate bodyunhindered, said distal slidable member comprising a substantially flatdistal edge; and a channel (206) passing through said distal slidablemember through which the second leg of said loop formed by saidconnecting wire passes; a plurality of additional slidable members (2)disposed within said track and adapted to slide along it while allowingsaid needle and one leg of said loop formed by said connecting wire topass through said hollow elongate body unhindered, each of saidadditional slidable members comprising a channel passing through saiddistal slidable member through which the second leg of said loop formedby said connecting wire passes; and a rigid circular hollow tubeactuator (6) disposed within said body proximally to the most proximallylocated slidable member, said activator disposed so as to engage saidrigid circular hollow tube control; wherein said slidable membersprovide a constant tool profile during said arthroscopic surgery.

It is another object of the present invention to provide the circularbone tunneling device as defined above, wherein said slidable members(2, 4) have the shape of a cylinder with an indentation (204, 404) aboutits circumference, said channel (206) passing through said cylinderwithin indentation substantially perpendicular to the longitudinal axisof said cylinder.

It is another object of the present invention to provide the circularbone tunneling device as defined above, wherein said handle comprises adistally located movable segment (12A) and a proximally locatedstationary segment (12B), said movable segment in physical connectionwith said support element driving mechanism.

It is another object of the present invention to provide the circularbone tunneling device as defined above, further incorporating indicatingmeans for indicating the movement, along said arc, of said rigidcircular hollow tube.

It is another object of the present invention to provide the circularbone tunneling device as defined above, wherein said indicating meanscomprise

a window disposed on one side of said shaft; and,

an indicator located within said shaft, physically connected to saidrigid circular hollow tube's driving mechanism such that the distancethrough which said indicator travels is proportional to the distance thedistal end of said rigid circular hollow tube travels, and disposed suchthat at least part of the travel of said indicator is visible throughsaid window.

It is another object of the present invention to provide the circularbone tunneling device as defined above, further comprising a mark onsaid side of said shaft in which said window is disposed, said mark islocated such that when said indicator reaches said mark, the distal endof said rigid circular hollow tube is fully extended.

It is another object of the present invention to provide the circularbone tunneling device as defined above, additionally comprising a needlecontrol adapted to control the forward and reverse movement of saidneedle along said path.

It is another object of the present invention to provide the circularbone tunneling device as defined above, wherein said needle controlcomprises a rotatable knob (18) in communication with said needle suchthat the forward and reverse movement of needle is proportional to therotation of said rotatable handle.

It is another object of the present invention to provide the circularbone tunneling device as defined above, wherein said needle controlimparts sufficient force to said needle such that the same is providedwith sufficient force to penetrate bone.

It is another object of the present invention to provide the circularbone tunneling device as defined above, wherein said sufficient force isin the range of about 500 to about 600 Newton.

It is another object of the present invention to provide the circularbone tunneling device as defined above, wherein said hollow elongatebody further comprises at least one body slot (330) along at least partof its length, said hollow elongate body head further comprising atleast one hollow elongate body head slot (390) along at least part ofits length, and said rigid circular hollow tube's driving mechanismcomprises:

a rigid circular hollow tube actuator (6) physically connected to saidrigid circular hollow tube control, said rigid circular hollow tubeactuator disposed within said elongate hollow body and adapted to slidealong the proximal-distal axis of said hollow body; and,

a yoke (300) disposed external to said hollow elongate body, said yokepivotably connected substantially at its proximal end to said rigidcircular hollow tube actuator via a connection that passes through saidbody slot (330) and at pivotably connected substantially at its distalend to said rigid circular hollow tube via a connection that passesthrough said hollow elongate body head slot (390).

It is another object of the present invention to provide the circularbone tunneling device as defined above, wherein said support elementdriving mechanism comprises an actuator (58) adapted to reconfigure saidsupport element to said retracted configuration to said extendedconfiguration and vice versa.

It is another object of the present invention to provide the circularbone tunneling device as defined above, wherein said support elementdriving mechanism comprises a yoke (340) pivotably connected at itsproximal end to said actuator (58) and pivotably connected to saidsupport element.

It is another object of the present invention to provide the circularbone tunneling device as defined above, wherein at least one selectedfrom a group consisting of said support element, said needle and anycombination thereof is actuated mechanically by a motor.

It is another object of the present invention to provide the circularbone tunneling device as defined above, wherein said needle ischaracterized by having cross sectional area selected from a groupconsisting of circular, triangular, rectangular, flat or any combinationthereof.

It is another object of the present invention to provide the circularbone tunneling device as defined above, additionally comprising aretractable sleeve characterized by having at least two positions (a) anextended position, in which said sleeve completely encircles saidneedle; and, (b) retracted position, in which said needle partiallyprotrudes out of said retractable sleeve.

It is another object of the present invention to provide the circularbone tunneling device as defined above, additionally comprising at leastone anchor, in mechanical communication with said suture.

It is another object of the present invention to provide the circularbone tunneling device as defined above, wherein said needle is adaptedto engage with said anchor so as to encase said suture.

It is another object of the present invention to provide the circularbone tunneling device as defined above, wherein said engagement of saidsuture with said anchor forms at least one loop.

It is another object of the present invention to provide the circularbone tunneling device as defined above, wherein n additional sutures areinterleaved and threaded through said loop; n is an integer greater than1.

It is another object of the present invention to provide a method fortunneling through a bone during arthroscopic surgery, said methodcomprising steps of:

providing a curved bone tunneling device comprising:

-   -   a hollow elongate body comprising a hollow elongate body head,        said a hollow elongate body head defining a rigid circular arc;        said hollow elongate body head comprising a surgical needle        adapted to tunnel through a bone along a path formed by said        rigid circular arc; an extendable and retractable support        element, reconfigurable from at least one extended configuration        to at least one retracted configuration; and, a stabilizing        element reconfigurable from at least one extended configuration        to at least one retracted configuration; wherein said        stabilizing element in said extended configuration, is adapted        to be in physical contact with said bone so as to reversibly        fixate the orientation of said circular bone tunneling device        relative to said bone;

positioning said hollow elongate body of said device adjacent to thecircumference of a bone;

fixating said needle to said bone;

extending said retractable support element to a location along the pathformed by said circular arc; thereby grasping said bone with saidsupport element and said hollow elongate body at two points along thecircumference of said bone;

extending said stabilizing element so as to reconfigure the same fromsaid retracted configuration to said extended configuration; therebyreversibly fixating the orientation of said curved bone tunneling devicerelative to said bone;

actuating said needle, thereby tunneling through said bone along saidcircular arc path;

inserting said needle into said support element once said needle hasbeen extracted out of said bone;

loading said suture onto said needle;

retracting said needle out of said bone.

It is another object of the present invention to provide the method asdefined above, additionally comprising step of reciprocally moving saidstabilizing element along the main longitudinal axis of said circularbone tunneling device so as to be reconfigured from said extendedconfiguration to said retracted configuration and vice versa.

It is another object of the present invention to provide the method asdefined above, additionally comprising step of pivotally coupling saidstabilizing element, at a pivot point, to the distal end of said hollowelongate body at a pivot point of said circular bone tunneling device.

It is another object of the present invention to provide the method asdefined above, wherein said stabilizing element is adapted to radiallyand pivotably rotate around said pivot point so as to be reconfiguredfrom said extended configuration to said retracted configuration andvice versa.

It is another object of the present invention to provide the method asdefined above, wherein said stabilizing element in said extendedconfiguration is adapted to be reversibly anchored within said bone.

It is another object of the present invention to provide the method asdefined above, wherein said stabilizing element comprises a distal endand a proximal end; said distal end comprises a flange and a tip; saidtip is adapted to penetrate said bone and to reversibly anchor saidstabilizing element within the same.

It is another object of the present invention to provide the method asdefined above, said flange is adapted to limit the insertion of saiddistal end of said stabilizing element into said bone such that onlysaid tip is reversibly anchored within said bone.

It is another object of the present invention to provide the method asdefined above, wherein the shape of said tip of said stabilizing elementis selected from a group consisting of nail-like tip, screw-like tip andany combination thereof.

It is another object of the present invention to provide the method asdefined above, additionally comprising step of providing saidstabilizing element with at least one marker, adapted to indicate theuser as for said stabilizing element position with respect to the bone.

It is another object of the present invention to provide the method asdefined above, additionally comprising step of providing said devicefurther with an indicator; said indicator is provided with a yardstickhaving numerical references on the same; said numerical references areadapted to indicate to the user the depth of penetration of saidstabilizing element into said the bone.

It is another object of the present invention to provide the method asdefined above, additionally comprising step of providing said devicewith a locking mechanism adapted to lock said stabilizing element in thedesired position.

It is another object of the present invention to provide the method asdefined above, additionally comprising step of providing said circularbone tunneling device with at least one suture cartridge comprising asuture; said suture is adapted to be passed through said circulartransosseous tunnel previously tunneled through said bone.

It is another object of the present invention to provide the method asdefined above, additionally comprising step of linearly moving saidsuture cartridge in the direction of said support element; therebyloading said suture onto said support element.

It is another object of the present invention to provide the method asdefined above, wherein said suture cartridge comprising an externalscaffold enclosing an inner body throughout which a surgical tool isinserted.

It is another object of the present invention to provide the method asdefined above, wherein said inner body is characterized by havingdiameter of at least 3 mm.

It is another object of the present invention to provide the method asdefined above, additionally comprising step of selecting said surgicaltool is a group consisting of grasper, tendon holder, scissors,diathermy, scalpel, stapler, jig, suturing means, and any combinationthereof

It is another object of the present invention to provide the method asdefined above, further comprising a step of providing said device with ashaft, parallel to said device's main longitudinal axis; wherein saidhollow elongate body head located at the distal end of said shaft anddefining said rigid circular arc with the concave side of said arcforming said underside of said hollow elongate body head.

It is another object of the present invention to provide the method asdefined above, wherein said shaft additionally comprising an innerelongated hollow tube throughout which a surgical tool is inserted.

It is another object of the present invention to provide the method asdefined above, wherein said inner elongated hollow tube is characterizedby having diameter of at least 3 mm.

It is another object of the present invention to provide the method asdefined above, additionally comprising step of selecting said surgicaltool from a group consisting of grasper, tendon holder, scissors,diathermy, scalpel, stapler, jig, suturing means, and any combinationthereof.

It is another object of the present invention to provide the method asdefined above, wherein said suture cartridge is coupled to said shaftand adapted to reciprocally move along the main longitudinal axis of thesame.

It is another object of the present invention to provide the method asdefined above, wherein said support element comprises at least one hookadapted to encase said suture.

It is another object of the present invention to provide the method asdefined above, wherein said movement of said suture cartridge in thedirection of said support element loads said suture onto said hook ofsaid support element.

It is another object of the present invention to provide the method asdefined above, wherein said surgical needle is a rigid surgical needle.

It is another object of the present invention to provide the method asdefined above, wherein said surgical needle is either straight or curvedand shaped as circular arc.

It is another object of the present invention to provide the method asdefined above, wherein said needle is adapted to engage with saidsupport element once said needle has tunneled through and exited saidbone along said arced path.

It is another object of the present invention to provide the method asdefined above, wherein said needle comprises catching means adapted tocatch and encase said suture once said needle engages with said supportelement.

It is another object of the present invention to provide the method asdefined above, wherein said catching means are selected from a groupconsisting of mechanical means, magnetically, electrical means or anycombination thereof.

It is another object of the present invention to provide the method asdefined above, wherein said mechanical means are at least one hookadapted to encase said suture once said needle engages with said supportmember.

It is another object of the present invention to provide the method asdefined above, wherein said needle comprises at least one hook adaptedto encase said suture once said needle engages with said support member.

It is another object of the present invention to provide the method asdefined above, wherein said extendable and retractable support element(54) is attached to the distal end of said shaft and structured andconfigured such that when said support element is extended, it opposesthe underside of said curved hollow elongate body head and its distalend is located along the path formed by said rigid circular arc.

It is another object of the present invention to provide the method asdefined above, wherein said hollow elongate body head comprising anarc-like shaft along which said support member is guided along tracks soas to be reconfigured to said extended configuration.

It is another object of the present invention to provide the method asdefined above, additionally comprising step of providing said devicewith a support element driving mechanism, adapted, upon activation of asupport element control, to drive the motion of said support element.

It is another object of the present invention to provide the method asdefined above, wherein upon activation of said support element, the sameis extended, such that said bone is being grasped by and between saidextendable and retractable support element and said head.

It is another object of the present invention to provide the method asdefined above, wherein the distal end of said hollow elongate body headcomprises an orifice through which a rigid circular hollow tube passesthrough.

It is another object of the present invention to provide the method asdefined above, wherein the extendable and retractable support element isadapted to reach, upon various degrees of extension, a predeterminedlocation relative to the distal end of said rigid circular hollow tube,such that the distance between said distal end of said rigid circularhollow tube and the upper side of said support element provides a slipfit over a bone through which a suture is to be passed.

It is another object of the present invention to provide the method asdefined above, additionally comprising a handle (12).

It is another object of the present invention to provide the method asdefined above, wherein said handle is either a reusable handle or asingle use handle.

It is another object of the present invention to provide the method asdefined above, wherein said arthroscopic surgery is performed withoutthe need of drilling through said bone.

It is another object of the present invention to provide the method asdefined above, wherein said hollow elongate body comprises:

at least one track (522) disposed within said hollow elongate body;

a connecting wire (132), forming a loop within said hollow elongatebody, the proximal end of said loop physically connected to said rigidcircular hollow tube control mechanism;

a distal slidable member (4) disposed within said track and adapted toslide within said track while maintaining said needle and one leg ofsaid loop formed by said connecting wire to pass through said hollowelongate body unhindered, said distal slidable member comprising:

-   -   a substantially flat distal edge; and,    -   a channel (206) passing through said distal slidable member        through which the second leg of said loop formed by said        connecting wire passes;

a plurality of additional slidable members (2) disposed within saidtrack and adapted to slide along it while allowing said needle and oneleg of said loop formed by said connecting wire to pass through saidhollow elongate body unhindered, each of said additional slidablemembers comprising a channel passing through said distal slidable memberthrough which the second leg of said loop formed by said connecting wirepasses; and,

a rigid circular hollow tube actuator (6) disposed within said bodyproximally to the most proximally located slidable member, saidactivator disposed so as to engage said rigid circular hollow tubecontrol; wherein said slidable members provides a constant tool profileduring said arthroscopic surgery.

It is another object of the present invention to provide the method asdefined above, wherein said slidable members (2,4) have the shape of acylinder with an indentation (204, 404) about its circumference, saidchannel (206) passing through said cylinder within indentationsubstantially perpendicular to the longitudinal axis of said cylinder.It is another object of the present invention to provide the method asdefined above, wherein said handle comprises a distally located movablesegment (12A) and a proximally located stationary segment (12B), saidmovable segment in physical connection with said support element drivingmechanism.

It is another object of the present invention to provide the method asdefined above, further incorporating indicating means for indicating themovement, along said acr, of said rigid circular hollow tube.

It is another object of the present invention to provide the method asdefined above, wherein said indicating means comprise a window disposedon one side of said shaft; and an indicator located within said shaft,physically connected to said rigid circular hollow tube's drivingmechanism such that the distance through which said indicator travels isproportional to the distance the distal end of said rigid circularhollow tube travels, and disposed such that at least part of the travelof said indicator is visible through said window.

It is another object of the present invention to provide a circular bonetunneling device as defined above, wherein said indicating meanscomprise: a needle indicator in physical communication with the proximalend of actuating means for said rigid circular hollow tube, said needleindicator comprising at least one element visible to the operator ofsaid circular bone tunneling device that undergoes linear motionproportional to the motion of said circular hollow tube; and a supportindicator in physical communication with the actuating means for saidsupport element, said support indicator comprising at least one elementvisible to the operator of said circular bone tunneling device thatundergoes linear motion proportional to the motion of said supportelement.

It is another object of the present invention to provide the method asdefined above, further comprising a mark on said side of said shaft inwhich said window is located, said mark disposed such that when saidindicator reaches said mark, the distal end of said rigid circularhollow tube is fully extended.

It is another object of the present invention to provide the method asdefined above, additionally comprising step of providing said devicewith a needle control adapted to control the forward and reversemovement of the needle along said path.

It is another object of the present invention to provide the method asdefined above, wherein said needle control comprises a rotatable handle(18) in communication with said needle such that the forward and reversemovement of needle is proportional to the rotation of said rotatablehandle.

It is another object of the present invention to provide the method asdefined above, wherein said needle control imparts sufficient force tosaid needle such that the same is provided with sufficient force topenetrate bone.

It is another object of the present invention to provide the method asdefined above, wherein said sufficient force is in the range of about500 to about 600 Newton.

It is another object of the present invention to provide the method asdefined above, wherein said hollow elongate body further comprises atleast one body slot (330) along at least part of its length, said hollowelongate body head further comprising at least one hollow elongate bodyhead slot (390) along at least part of its length, and said rigidcircular hollow tube's driving mechanism comprises:

a rigid circular hollow tube actuator (6) physically connected to saidrigid circular hollow tube control, said rigid circular hollow tubeactuator disposed within said elongate hollow body and adapted to slidealong the proximal-distal axis of said hollow body; and,

a yoke (300) disposed external to said hollow elongate body, said yokepivotably connected substantially at its proximal end to said rigidcircular hollow tube actuator via a connection that passes through saidbody slot (330) and at pivotably connected substantially at its distalend to said rigid circular hollow tube via a connection that passesthrough said hollow elongate body head slot (390).

It is another object of the present invention to provide the method asdefined above, wherein said support element driving mechanism comprisesan actuator (58) adapted to reconfigure said support element to saidretracted configuration to said extended configuration and vice versa.

It is another object of the present invention to provide the method asdefined above, wherein said support element driving mechanism comprisesa yoke (340) pivotably connected at its proximal end to said actuator(58) and pivotably connected to said support element.

It is another object of the present invention to provide the method asdefined above, wherein at least one selected from a group consisting ofsaid support element, said needle and any combination thereof isactuated mechanically by a motor.

It is another object of the present invention to provide the method asdefined above, wherein said needle is characterized by having crosssectional area selected from a group consisting of circular, triangular,rectangular, flat, or any combination thereof.

It is another object of the present invention to provide the method asdefined above, additionally comprising step of providing said devicewith a retractable sleeve characterized by having at least two positions(a) an extended position, in which said sleeve completely encircles saidneedle; and, (b) retracted position, in which said needle partiallyprotrudes out of said retractable sleeve.

It is another object of the present invention to provide the method asdefined above, additionally comprising step of providing said devicewith at least one anchor, in mechanical communication with said suture.

It is another object of the present invention to provide the method asdefined above, wherein said needle is adapted to engage with said anchorso as to encase said suture.

It is another object of the present invention to provide the method asdefined above, wherein said engagement of said suture with said anchorforms at least one loop.

It is another object of the present invention to provide the method asdefined above, wherein n additional sutures are interleaved and threadedthrough said loop; n is an integer greater than 1.

The circular bone tunneling device as defined above, wherein said needleis characterized by having cross sectional area selected from a groupconsisting of circular, triangular, rectangular, flat or any combinationthereof.

It is another object of the present invention to provide the circularbone tunneling device as defined above, wherein said handle is attachedto the body of said device so as to permit translation of said handle inthe proximal-distal direction relative to the body, rotation of saidhandle about its longitudinal axis, and fixing of the position of saidhandle.

It is another object of the present invention to provide the circularbone tunneling device as defined above, wherein said indicating meanscomprise:

a needle indicator in physical communication with the proximal end ofactuating means for said rigid circular hollow tube, said needleindicator comprising at least one element visible to the operator ofsaid circular bone tunneling device that undergoes linear motionproportional to the motion of said circular hollow tube; and,

a support indicator in physical communication with the actuating meansfor said support element, said support indicator comprising at least oneelement visible to the operator of said circular bone tunneling devicethat undergoes linear motion proportional to the motion of said supportelement.

It is another object of the present invention to provide the circularbone tunneling device as defined above, wherein said yoke comprises asingle prong disposed on one side of said shaft.

It is another object of the present invention to provide the circularbone tunneling device as defined above, further comprising a surgicaltool disposed within said shaft.

It is another object of the present invention to provide the circularbone tunneling device as defined above, wherein said surgical tool isselected from a group consisting of grasper, tendon holder, scissors,diathermy, scalpel, stapler, jig, suturing means, and any combinationthereof.

It is another object of the present invention to provide the circularbone tunneling device as defined above, further comprising an extendablejig disposed within said shaft.

It is another object of the present invention to provide the method asdefined above, wherein said needle is characterized by having crosssectional area selected from a group consisting of circular, triangular,rectangular, flat or any combination thereof.

It is another object of the present invention to provide the method asdefined above, wherein said handle is attached to the body of saiddevice so as to permit translation of said handle in the proximal-distaldirection relative to the body, rotation of said handle about itslongitudinal axis, and fixing of the position of said handle.

It is another object of the present invention to provide the method asdefined above, wherein said indicating means comprise:

a needle indicator in physical communication with the proximal end ofactuating means for said rigid circular hollow tube, said needleindicator comprising at least one element visible to the operator ofsaid circular bone tunneling device that undergoes linear motionproportional to the motion of said circular hollow tube; and,

a support indicator in physical communication with the actuating meansfor said support element, said support indicator comprising at least oneelement visible to the operator of said circular bone tunneling devicethat undergoes linear motion proportional to the motion of said supportelement.

It is another object of the present invention to provide the method asdefined above, wherein said yoke comprises a single prong disposed onone side of said shaft.

It is another object of the present invention to provide the method asdefined above, further comprising a surgical tool disposed within saidshaft.

It is another object of the present invention to provide the method asdefined above, wherein said surgical tool is selected from a groupconsisting of grasper, tendon holder, scissors, diathermy, scalpel,stapler, jig, suturing means, and any combination thereof.

It is another object of the present invention to provide the method asdefined above, further comprising an extendable jig disposed within saidshaft.

It is therefore another object to provide a circular bone tunnelingdevice for use in arthroscopic surgery, comprising: a hollow elongatebody comprising a hollow elongate body head, said a hollow elongate bodyhead defining a rigid circular arc; said hollow elongate body headcomprising a surgical needle adapted to tunnel through a bone along apath formed by said rigid circular arc; and, an extendable andretractable support element, reconfigurable from at least one extendedconfiguration to at least one retracted configuration; said supportelement, in said extended configuration, is adapted to be located alongsaid path formed by said rigid circular arc; said support element, insaid extended configuration, and said hollow elongate body head areadapted to grasp said bone from at least two points along thecircumference of said bone; a suture cartridge comprising a suture to bepassed through said circular arc tunneled through said bone.

It is another object of the present invention to provide the circularbone tunneling device as defined above, wherein said suture cartridgecomprising an external scaffold enclosing an inner body throughout whicha surgical tool is inserted.

It is another object of the present invention to provide the circularbone tunneling device as defined above, wherein said inner body ischaracterized by having diameter of at least 3 mm.

It is another object of the present invention to provide the circularbone tunneling device as defined above, wherein said surgical tool isselected from a group consisting of grasper, tendon holder, scissors,diathermy, scalpel, stapler, jig, suturing means, and any combinationthereof.

It is another object of the present invention to provide the circularbone tunneling device as defined above, further comprising a shaft;wherein said hollow elongate body head located at the distal end of saidshaft and defining said rigid circular arc with the concave side of saidarc forming said underside of said hollow elongate body head.

It is another object of the present invention to provide the circularbone tunneling device as defined above, wherein said shaft additionallycomprising an inner elongated hollow tube throughout which a surgicaltool is inserted.

It is another object of the present invention to provide the circularbone tunneling device as defined above, wherein said inner elongatedhollow tube is characterized by having diameter of at least 3 mm.

It is another object of the present invention to provide the circularbone tunneling device as defined above, wherein said surgical tool isselected from a group consisting of grasper, tendon holder, scissors,diathermy, scalpel, stapler, jig, suturing means, and any combinationthereof.

It is another object of the present invention to provide the circularbone tunneling device as defined above, wherein said suture cartridge iscoupled to said shaft and adapted to reciprocally move along the mainlongitudinal axis of the same.

It is another object of the present invention to provide the circularbone tunneling device as defined above, wherein said support elementcomprises at least one hook adapted to encase said suture.

It is another object of the present invention to provide the circularbone tunneling device as defined above, wherein said movement of saidsuture cartridge in the direction of said support element loads saidsuture onto said hook of said support member.

It is another object of the present invention to provide the circularbone tunneling device as defined above, wherein said surgical needle isa rigid surgical needle.

It is another object of the present invention to provide the circularbone tunneling device as defined above, wherein said surgical needle iseither straight or curved and shaped as circular arc.

It is another object of the present invention to provide the circularbone tunneling device as defined above, wherein said needle is adaptedto engage with said support member once said needle has tunneled throughsaid bone along said arc-like path.

It is another object of the present invention to provide the circularbone tunneling device as defined above, wherein said needle comprisesmeans adapted to catch and encase said suture once said needle engageswith said support member.

It is another object of the present invention to provide the circularbone tunneling device as defined above, wherein said means are selectedfrom a group consisting of mechanical means, magnetically, electricalmeans or any combination thereof.

It is another object of the present invention to provide the circularbone tunneling device as defined above, wherein said mechanical meansare at least one hook adapted to encase said suture once said needleengages with said support member.

It is another object of the present invention to provide the circularbone tunneling device as defined above, wherein said needle comprises atleast one hook adapted to encase said suture once said needle engageswith said support member.

It is another object of the present invention to provide the circularbone tunneling device as defined above, wherein said extendable andretractable support element (54) is attached to the distal end of saidshaft and disposed such that when said support element is extended, itopposes the underside of said curved hollow elongate body head and itsdistal end is located along the path formed by said rigid circular arc.

It is another object of the present invention to provide the circularbone tunneling device as defined above, wherein said hollow elongatebody head comprising an arc-like shaft along which said support memberslides so as to be reconfigured to said extended configuration.

It is another object of the present invention to provide the circularbone tunneling device as defined above, additionally comprising asupport element driving mechanism, adapted, upon activation of a supportelement control, to drive the motion of said support element.

It is another object of the present invention to provide the circularbone tunneling device as defined above, wherein upon activation of saidsupport element, the same is extended, such that said bone is beinggrasped by said extendable and retractable support element and saidhead.

It is another object of the present invention to provide the circularbone tunneling device as defined above, wherein the extendable andretractable support element is adapted to reach, upon extension, apredetermined location relative to the distal end of said rigid circularhollow tube, such that the distance between said distal end of saidrigid circular hollow tube and the upper side of said support elementprovides a slip fit over a bone through which a suture is to be passed.

It is another object of the present invention to provide the circularbone tunneling device as defined above, additionally comprising a handle(12).

It is another object of the present invention to provide the circularbone tunneling device as defined above, wherein said handle is either areusable handle or a single use handle.

It is another object of the present invention to provide the circularbone tunneling device as defined above, wherein said arthroscopicsurgery is performed without the need of drilling through said bone.

It is another object of the present invention to provide the circularbone tunneling device as defined above, wherein said hollow elongatebody comprises: at least one track (522) disposed within said hollowelongate body; a connecting wire (132), forming a loop within saidhollow elongate body, the proximal end of said loop physically connectedto said rigid circular hollow tube control mechanism; a distal slidablemember (4) disposed within said track and adapted to slide along itwhile allowing said needle and one leg of said loop formed by saidconnecting wire to pass through said hollow elongate body unhindered,said distal slidable member comprising a substantially flat distal edge;and a channel (206) passing through said distal slidable member throughwhich the second leg of said loop formed by said connecting wire passes;a plurality of additional slidable members (2) disposed within saidtrack and adapted to slide along it while allowing said needle and oneleg of said loop formed by said connecting wire to pass through saidhollow elongate body unhindered, each of said additional slidablemembers comprising a channel passing through said distal slidable memberthrough which the second leg of said loop formed by said connecting wirepasses; and a rigid circular hollow tube actuator (6) disposed withinsaid body proximally to the most proximally located slidable member,said activator disposed so as to engage said rigid circular hollow tubecontrol; wherein said slidable members provide a constant tool profileduring said arthroscopic surgery.

It is another object of the present invention to provide the circularbone tunneling device as defined above, wherein said slidable members(2,4) have the shape of a cylinder with an indentation (204) about itscircumference, said channel (206) passing through said cylinder withinindentation substantially perpendicular to the longitudinal axis of saidcylinder.

It is another object of the present invention to provide the circularbone tunneling device as defined above, wherein said handle comprises adistally located movable segment (12A) and a proximally locatedstationary segment (12B), said movable segment in physical connectionwith said support element driving mechanism.

It is another object of the present invention to provide the circularbone tunneling device as defined above, further incorporating indicatingmeans for indicating the extent of travel, along said arc, of said rigidcircular hollow tube.

It is another object of the present invention to provide the circularbone tunneling device as defined above, wherein said indicating meanscomprise

a window disposed on one side of said shaft; and,

an indicator located within said shaft, physically connected to saidrigid circular hollow tube driving mechanism such that the distancethrough which said indicator travels is proportional to the distance thedistal end of said rigid circular hollow tube travels, and disposed suchthat at least part of the travel of said indicator is visible throughsaid window.

It is another object of the present invention to provide the circularbone tunneling device as defined above, further comprising a mark onsaid side of said shaft in which said window is disposed, said markdisposed such that when said indicator reaches said mark, the distal endof said rigid circular hollow tube is fully extended.

It is another object of the present invention to provide the circularbone tunneling device as defined above, additionally comprising a needlecontrol adapted to control the amount of movement the needle hastraveled.

It is another object of the present invention to provide the circularbone tunneling device as defined above, wherein said needle controlcomprises a rotatable handle (18) in communication with said needle suchthat the distance through which said needle travels is proportional tothe rotational angle through which said rotatable handle is rotated.

It is another object of the present invention to provide the circularbone tunneling device as defined above, wherein said needle controlimparts sufficient force to said needle such that the same is providedwith sufficient force to penetrate bone.

It is another object of the present invention to provide the circularbone tunneling device as defined above, wherein said sufficient force isin the range of about 500 to about 600 Newton.

It is another object of the present invention to provide the circularbone tunneling device as defined above, wherein said hollow elongatebody further comprises at least one body slot (330) along at least partof its length, said hollow elongate body head further comprising atleast one hollow elongate body head slot (390) along at least part ofits length, and said rigid circular hollow tube driving mechanismcomprises:

a rigid circular hollow tube actuator (310) physically connected to saidrigid circular hollow tube control, said rigid circular hollow tubeactuator disposed within said elongate hollow body and adapted to slidealong the proximal-distal axis of said hollow body; and,

a yoke (300) disposed external to said hollow elongate body, said yokepivotably connected substantially at its proximal end to said rigidcircular hollow tube actuator via a connection that passes through saidbody slot (330) and at pivotably connected substantially at its distalend to said rigid circular hollow tube via a connection that passesthrough said hollow elongate body head slot (390).

It is another object of the present invention to provide the circularbone tunneling device as defined above, wherein said support elementdriving mechanism comprises an actuator (58) adapted to reconfigure saidsupport element to said retracted configuration to said extendedconfiguration and vice versa.

It is another object of the present invention to provide the circularbone tunneling device as defined above, wherein said support elementdriving mechanism comprises a yoke (340) pivotably connected at itsproximal end to said actuator (58) and pivotably connected to saidsupport element.

It is another object of the present invention to provide the circularbone tunneling device as defined above, wherein at least one selectedfrom a group consisting of said support element, said needle and anycombination thereof is actuated mechanically by a motor.

It is another object of the present invention to provide the circularbone tunneling device as defined above, wherein said needle ischaracterized by having cross sectional area selected from a groupconsisting of circular, triangular, rectangular, flat or any combinationthereof.

It is another object of the present invention to provide the circularbone tunneling device as defined above, additionally comprising aretractable sleeve characterized by having at least two positions (a) anextended position, in which said sleeve completely encircles saidneedle; and, (b) retracted position, in which said needle partiallyprotrudes out of said retractable sleeve.

It is another object of the present invention to provide the circularbone tunneling device as defined above, additionally comprising at leastone anchor, in mechanical communication with said suture.

It is another object of the present invention to provide the circularbone tunneling device as defined above, wherein said needle is adaptedto engage with said anchor so as to encase said suture.

It is another object of the present invention to provide the circularbone tunneling device as defined above, wherein said anchor comprisesmeans adapted to enable interleave of n additional sutures threadedthrough the same; n is an integer greater than 1.

It is another object of the present invention to provide a method fortunneling through a bone during arthroscopic surgery, said methodcomprising steps of:

a. providing a curved bone tunneling device comprising: a hollowelongate body comprising a hollow elongate body head, said a hollowelongate body head defining a rigid circular arc; said hollow elongatebody head comprising a surgical needle adapted to tunnel through a bonealong a path formed by said rigid circular arc;

-   -   an extendable and retractable support element, reconfigurable        from at least one extended configuration to at least one        retracted configuration; and,    -   a suture cartridge comprising a suture;    -   b. positioning said hollow elongate body of said device adjacent        to the circumference of a bone;    -   c. fixating said needle to said bone;    -   d. extending said retractable support element to a location        along the path formed by said circular arc; thereby grasping        said bone with said support element and said hollow elongate        body at two points along the circumference of said bone;    -   e. linearly moving said suture cartridge in the direction of        said support element; thereby loading said suture onto said        support element;    -   f. actuating said needle, thereby tunneling through said bone        along said circular arc path;    -   g. inserting said needle into said support element once said        needle has been extracted out of said bone;    -   h. loading said suture onto said needle;    -   i. retracting said needle out of said bone;    -   j. wherein said step of tunneling through said bone is performed        without drilling.

It is another object of the present invention to provide the method asdefined above, wherein said suture cartridge comprising an externalscaffold enclosing an inner body throughout which a surgical tool isinserted.

It is another object of the present invention to provide the method asdefined above, wherein said inner body is characterized by havingdiameter of at least 3 mm.

It is another object of the present invention to provide the method asdefined above, additionally comprising step of selecting said surgicaltool is a group consisting of grasper, tendon holder, scissors,diathermy, scalpel, stapler, jig, suturing means, and any combinationthereof

It is another object of the present invention to provide the method asdefined above, further comprising a step of providing said device with ashaft; wherein said hollow elongate body head located at the distal endof said shaft and defining said rigid circular arc with the concave sideof said arc forming said underside of said hollow elongate body head.

It is another object of the present invention to provide the method asdefined above, wherein said shaft additionally comprising an innerelongated hollow tube throughout which a surgical tool is inserted.

It is another object of the present invention to provide the method asdefined above, wherein said inner elongated hollow tube is characterizedby having diameter of at least 3 mm.

It is another object of the present invention to provide the method asdefined above, additionally comprising step of selecting said surgicaltool from a group consisting of grasper, tendon holder, scissors,diathermy, scalpel, stapler, jig, suturing means, and any combinationthereof.

It is another object of the present invention to provide the method asdefined above, wherein said suture cartridge is coupled to said shaftand adapted to reciprocally move along the main longitudinal axis of thesame.

It is another object of the present invention to provide the method asdefined above, wherein said support element comprises at least one hookadapted to encase said suture.

It is another object of the present invention to provide the method asdefined above, wherein said movement of said suture cartridge in thedirection of said support element loads said suture onto said hook ofsaid support member.

It is another object of the present invention to provide the method asdefined above, wherein said surgical needle is a rigid surgical needle.

It is another object of the present invention to provide the method asdefined above, wherein said surgical needle is either straight or curvedand shaped as circular arc.

It is another object of the present invention to provide the method asdefined above, wherein said needle is adapted to engage with saidsupport member once said needle has tunneled through said bone alongsaid arc-like path.

It is another object of the present invention to provide the method asdefined above, wherein said needle comprises means adapted to catch andencase said suture once said needle engages with said support member.

It is another object of the present invention to provide the method asdefined above, wherein said means are selected from a group consistingof mechanical means, magnetically, electrical means or any combinationthereof.

It is another object of the present invention to provide the method asdefined above, wherein said mechanical means are at least one hookadapted to encase said suture once said needle engages with said supportmember.

It is another object of the present invention to provide the method asdefined above, wherein said needle comprises at least one hook adaptedto encase said suture once said needle engages with said support member.

It is another object of the present invention to provide the method asdefined above, wherein said extendable and retractable support element(54) is attached to the distal end of said shaft and disposed such thatwhen said support element is extended, it opposes the underside of saidcurved hollow elongate body head and its distal end is located along thepath formed by said rigid circular arc.

It is another object of the present invention to provide the method asdefined above, wherein said hollow elongate body head comprising anarc-like shaft along which said support member slides so as to bereconfigured to said extended configuration.

It is another object of the present invention to provide the method asdefined above, additionally comprising step of providing said devicewith a support element driving mechanism, adapted, upon activation of asupport element control, to drive the motion of said support element.

It is another object of the present invention to provide the method asdefined above, wherein upon activation of said support element, the sameis extended, such that said bone is being grasped by said extendable andretractable support element and said head.

It is another object of the present invention to provide the method asdefined above, wherein the extendable and retractable support element isadapted to reach, upon extension, a predetermined location relative tothe distal end of said rigid circular hollow tube, such that thedistance between said distal end of said rigid circular hollow tube andthe upper side of said support element provides a slip fit over a bonethrough which a suture is to be passed.

It is another object of the present invention to provide the method asdefined above, additionally comprising a handle (12).

It is another object of the present invention to provide the method asdefined above, wherein said handle is either a reusable handle or asingle use handle.

It is another object of the present invention to provide the method asdefined above, wherein said arthroscopic surgery is performed withoutthe need of drilling through said bone.

It is another object of the present invention to provide the method asdefined above, wherein said hollow elongate body comprises:

(a) at least one track (522) disposed within said hollow elongate body;

(b) a connecting wire (132), forming a loop within said hollow elongatebody, the proximal end of said loop physically connected to said rigidcircular hollow tube control mechanism;

(c) a distal slidable member (4) disposed within said track and adaptedto slide along it while allowing said needle and one leg of said loopformed by said connecting wire to pass through said hollow elongate bodyunhindered, said distal slidable member comprising:

-   -   i. a substantially flat distal edge; and,    -   ii. a channel (206) passing through said distal slidable member        through which the second leg of said loop formed by said        connecting wire passes;

(d) a plurality of additional slidable members (2) disposed within saidtrack and adapted to slide along it while allowing said needle and oneleg of said loop formed by said connecting wire to pass through saidhollow elongate body unhindered, each of said additional slidablemembers comprising a channel passing through said distal slidable memberthrough which the second leg of said loop formed by said connecting wirepasses; and,

(e) a rigid circular hollow tube actuator (6) disposed within said bodyproximally to the most proximally located slidable member, saidactivator disposed so as to engage said rigid circular hollow tubecontrol; wherein said slidable members provides a constant tool profileduring said arthroscopic surgery.

It is another object of the present invention to provide the method asdefined above, wherein said slidable members (2,4) have the shape of acylinder with an indentation (204) about its circumference, said channel(206) passing through said cylinder within indentation substantiallyperpendicular to the longitudinal axis of said cylinder. It is anotherobject of the present invention to provide the method as defined above,wherein said handle comprises a distally located movable segment (12A)and a proximally located stationary segment (12B), said movable segmentin physical connection with said support element driving mechanism.

It is another object of the present invention to provide the method asdefined above, further incorporating indicating means for indicating theextent of travel, along said arc, of said rigid circular hollow tube.

It is another object of the present invention to provide the method asdefined above, wherein said indicating means comprise a window disposedon one side of said shaft; and an indicator located within said shaft,physically connected to said rigid circular hollow tube drivingmechanism such that the distance through which said indicator travels isproportional to the distance the distal end of said rigid circularhollow tube travels, and disposed such that at least part of the travelof said indicator is visible through said window.

It is another object of the present invention to provide a circular bonetunneling device as defined above, wherein said indicating meanscomprise: a needle indicator in physical communication with the proximalend of actuating means for said rigid circular hollow tube, said needleindicator comprising at least one element visible to the operator ofsaid circular bone tunneling device that undergoes linear motionproportional to the motion of said circular hollow tube; and a supportindicator in physical communication with the actuating means for saidsupport element, said support indicator comprising at least one elementvisible to the operator of said circular bone tunneling device thatundergoes linear motion proportional to the motion of said supportelement.

It is another object of the present invention to provide the method asdefined above, further comprising a mark on said side of said shaft inwhich said window is disposed, said mark disposed such that when saidindicator reaches said mark, the distal end of said rigid circularhollow tube is fully extended.

It is another object of the present invention to provide the method asdefined above, additionally comprising step of providing said devicewith a needle control adapted to control the amount of movement theneedle has traveled.

It is another object of the present invention to provide the method asdefined above, wherein said needle control comprises a rotatable handle(18) in communication with said needle such that the distance throughwhich said needle travels is proportional to the rotational anglethrough which said rotatable handle is rotated.

It is another object of the present invention to provide the method asdefined above, wherein said needle control imparts sufficient force tosaid needle such that the same is provided with sufficient force topenetrate bone.

It is another object of the present invention to provide the method asdefined above, wherein said sufficient force is in the range of about500 to about 600 Newton.

It is another object of the present invention to provide the method asdefined above, wherein said hollow elongate body further comprises atleast one body slot (330) along at least part of its length, said hollowelongate body head further comprising at least one hollow elongate bodyhead slot (390) along at least part of its length, and said rigidcircular hollow tube driving mechanism comprises:

(a) a rigid circular hollow tube actuator (310) physically connected tosaid rigid circular hollow tube control, said rigid circular hollow tubeactuator disposed within said elongate hollow body and adapted to slidealong the proximal-distal axis of said hollow body; and,

(b) a yoke (300) disposed external to said hollow elongate body, saidyoke pivotably connected substantially at its proximal end to said rigidcircular hollow tube actuator via a connection that passes through saidbody slot (330) and at pivotably connected substantially at its distalend to said rigid circular hollow tube via a connection that passesthrough said hollow elongate body head slot (390).

It is another object of the present invention to provide the method asdefined above, wherein said support element driving mechanism comprisesan actuator (58) adapted to reconfigure said support element to saidretracted configuration to said extended configuration and vice versa.

It is another object of the present invention to provide the method asdefined above, wherein said support element driving mechanism comprisesa yoke (340) pivotably connected at its proximal end to said actuator(58) and pivotably connected to said support element.

It is another object of the present invention to provide the method asdefined above, wherein at least one selected from a group consisting ofsaid support element, said needle and any combination thereof isactuated mechanically by a motor.

It is another object of the present invention to provide the method asdefined above, wherein said needle is characterized by having crosssectional area selected from a group consisting of circular, triangular,rectangular, flat, or any combination thereof.

It is another object of the present invention to provide the method asdefined above, additionally comprising step of providing said devicewith a retractable sleeve characterized by having at least two positions(a) an extended position, in which said sleeve completely encircles saidneedle; and, (b) retracted position, in which said needle partiallyprotrudes out of said retractable sleeve.

It is another object of the present invention to provide the method asdefined above, additionally comprising step of providing said devicewith at least one anchor, in mechanical communication with said suture.

It is another object of the present invention to provide the method asdefined above, wherein said needle is adapted to engage with said anchorso as to encase said suture.

It is another object of the present invention to provide the method asdefined above, wherein said anchor comprises means adapted to enableinterleave of n additional sutures threaded through the same; n is aninteger greater than 1.

The circular bone tunneling device according to claim 1, wherein saidneedle is characterized by having cross sectional area selected from agroup consisting of circular, triangular, rectangular, flat or anycombination thereof.

It is another object of the present invention to provide the circularbone tunneling device as defined above, wherein said handle is attachedto the body of said device so as to permit translation of said handle inthe proximal-distal direction relative to the body, rotation of saidhandle about its longitudinal axis, and fixing of the position of saidhandle.

It is another object of the present invention to provide the circularbone tunneling device as defined above, wherein said indicating meanscomprise:

(a) a needle indicator in physical communication with the proximal endof actuating means for said rigid circular hollow tube, said needleindicator comprising at least one element visible to the operator ofsaid circular bone tunneling device that undergoes linear motionproportional to the motion of said circular hollow tube; and,

(b) a support indicator in physical communication with the actuatingmeans for said support element, said support indicator comprising atleast one element visible to the operator of said circular bonetunneling device that undergoes linear motion proportional to the motionof said support element.

It is another object of the present invention to provide the circularbone tunneling device as defined above, wherein said yoke comprises asingle prong disposed on one side of said shaft.

It is another object of the present invention to provide the circularbone tunneling device as defined above, further comprising a surgicaltool disposed within said shaft.

It is another object of the present invention to provide the circularbone tunneling device as defined above, wherein said surgical tool isselected from a group consisting of grasper, tendon holder, scissors,diathermy, scalpel, stapler, jig, suturing means, and any combinationthereof.

It is another object of the present invention to provide the circularbone tunneling device as defined above, further comprising an extendablejig disposed within said shaft.

It is another object of the present invention to provide the method asdefined above, wherein said needle is characterized by having crosssectional area selected from a group consisting of circular, triangular,rectangular, flat or any combination thereof.

It is another object of the present invention to provide the method asdefined above, wherein said handle is attached to the body of saiddevice so as to permit translation of said handle in the proximal-distaldirection relative to the body, rotation of said handle about itslongitudinal axis, and fixing of the position of said handle.

It is another object of the present invention to provide the method asdefined above, wherein said indicating means comprise:

(a) a needle indicator in physical communication with the proximal endof actuating means for said rigid circular hollow tube, said needleindicator comprising at least one element visible to the operator ofsaid circular bone tunneling device that undergoes linear motionproportional to the motion of said circular hollow tube; and,

(b) a support indicator in physical communication with the actuatingmeans for said support element, said support indicator comprising atleast one element visible to the operator of said circular bonetunneling device that undergoes linear motion proportional to the motionof said support element.

It is another object of the present invention to provide the method asdefined above, wherein said yoke comprises a single prong disposed onone side of said shaft.

It is another object of the present invention to provide the method asdefined above, further comprising a surgical tool disposed within saidshaft.

It is another object of the present invention to provide the method asdefined above, wherein said surgical tool is selected from a groupconsisting of grasper, tendon holder, scissors, diathermy, scalpel,stapler, jig, suturing means, and any combination thereof.

It is another object of the present invention to provide the method asdefined above, further comprising an extendable jig disposed within saidshaft.

BRIEF DESCRIPTION OF THE DRAWINGS

The invention disclosed herein is now described with reference to thedrawings, wherein:

FIGS. 1A, 1B and 1C present isometric drawings of the curved/circularbone tunneling device or adjustable suture passer herein disclosedaccording to one embodiment of the invention;

FIGS. 2A, 2B, 2C and 2D present views of the curved/circular bonetunneling device or adjustable suture passer herein disclosed in whichthe support element has been extended;

FIG. 3 presents a cross-sectional view of the distal end of thecurved/circular bone tunneling device or adjustable suture passer hereindisclosed illustrating its use to insert a guide wire through a bone;

FIG. 4 presents the same view as in FIG. 3, but after the supportelement has been retracted;

FIGS. 5A, 5B, 5C and 5D present views of the distal end of anotherpreferred embodiment of the invention;

FIGS. 6A, 6B, 6C and 6D present illustrations of slidable members 2 and4 according to a preferred embodiment of the invention;

FIG. 7 presents a cross-sectional view of the assembly of the rigidhollow tube driving mechanism according to a preferred embodiment of theinvention;

FIGS. 8A and 8B present isometric views of the rigid hollow tube controlaccording to a preferred embodiment of the invention;

FIGS. 9A, 9B and 9C present isometric views of the support elementcontrol according to a preferred embodiment of the invention;

FIG. 10 presents a view of the curved/circular bone tunneling device oradjustable suture passer disclosed herein according to anotherembodiment of the invention;

FIGS. 11A and 11B present interior views of the distal end of thecurved/circular bone tunneling device or adjustable suture passerdisclosed herein according to said second embodiment of the invention;

FIGS. 12A, 12B and 12C present a schematic view of a motorized controlsystem for the curved/circular bone tunneling device or adjustablesuture passer disclosed herein;

FIGS. 13A and 13B present a schematic view of an embodiment of thepresent invention in which it further comprises a tendon holder;

FIG. 14 presents a schematic view of an embodiment of the presentinvention, utilizing a motorized tool in which decoupling of the shaftis enabled;

FIGS. 15A and 15B present a schematic view of an embodiment of thepresent invention, utilizing a hollow tube having a combination circularand triangular cross sectional area;

FIGS. 16A and 16B illustrate another embodiment of the presentinvention, utilizing a slightly curved needle;

FIG. 17 schematically illustrates the dimensions of the hollow tubes;

FIGS. 18, 19 and 20 illustrate another embodiment of theextendable/retractable support element (54);

FIGS. 21 and 22 illustrate another embodiment of the needle 32;

FIGS. 23, 24, 25 and 26 illustrate the suture cartridge 500;

FIGS. 27A, 27B, 27C, 27D and 27E illustrate the loading mechanism 600for loading suture 130 onto the support element 54;

FIG. 28 illustrates the circular bone tunneling device once the suture130 has been loaded to the support element 54 and the needle has alreadypenetrated into the bone 1000;

FIGS. 29, 30 and 31 illustrate needle 32 engaging with the supportelement 54;

FIGS. 32 and 33 illustrate a working channel 503 being created througheither shaft 50 (FIG. 32) and/or through the inner body 502 of cartridge500 (FIG. 33);

FIG. 34 illustrates the incorporation of a working tool (e.g., grasper)1001 into the circular bone tunneling device;

FIGS. 35, 36, 37, 38, 39, 40, 41, 42, 43, 44, 45, 46, 47, 48 and 49illustrate the overall method of utilizing the circular bone tunnelingdevice;

FIGS. 50 and 51 illustrate the circular bone tunneling device eithermanually operated (FIG. 50) or automatically operated (FIG. 51);

FIG. 52 illustrates another embodiment of the present invention in whichat least a part of the same is disposable and a least a part of which isreusable;

FIGS. 53 and 54 illustrate another embodiment of the present inventionin which a retractable sleeve 1007 is provided;

FIGS. 55, 56, 57, 58, 59, 60, 61, 62, 63 and 64 illustrate anotherembodiment of the present invention in which anchoring means 1009 isbeing used;

FIGS. 65A, 65B and 65C illustrate an embodiment of the invention inwhich asymmetric support is provided to support element 54;

FIGS. 66A, 66B and 66C illustrate a flat needle 32 used in someembodiments of the invention;

FIGS. 67A and 67B illustrate an embodiment in which handle 12 can rotateand translate relative to driving mechanism housing 10;

FIGS. 68A, 68B, 68C, 68D, 68E and 68F illustrate an embodiment of theinvention that incorporates a jig used to indicate the location ofneedle 32;

FIGS. 69A, 69B, 69C and 69D illustrate an embodiment of the inventionthat includes indicators showing the locations of support element 54 andneedle 32;

FIG. 70 illustrates an embodiment utilizing a single use needlecartridge 5000.

FIGS. 71A and 71B illustrate the circular bone tunneling device utilizedas a sewing machine;

FIGS. 72, 73, 74, 75, 76, 77 and 78 illustrate another embodiment of thepresent invention, in which a stabilizing element 7200 is provided; and

FIGS. 79, 80, 81, 82, 83, 84 and 85 illustrate another embodiment of thestabilizing element 7200.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

In the following description, various aspects of the invention will bedescribed. For the purposes of explanation, specific details are setforth in order to provide a thorough understanding of the invention. Itwill be apparent to one skilled in the art that there are otherembodiments of the invention that differ in details without affectingthe essential nature thereof. Therefore the invention is not limited bythat which is illustrated in the figures and described in thespecification, but only as indicated in the accompanying claims, withthe proper scope determined only by the broadest interpretation of saidclaims.

The present invention provides a bone tunneling device that “grabs” andfirmly holds the bone at two different points along an arc and isstabilized by a stabilizing element that reduces the movement (degreesof freedom) by fixating the device to the bone at a third contact pointsuch that movement is minimized and the forces applied to the needlewill be facilitated to be able to drive into the bone and furtherinadvertent movement by the physician due to hand movements will notaffect the position of the device.

The present invention provides a circular bone tunneling device, for usein arthroscopic surgery, comprising:

a hollow elongate body comprising a hollow elongate body head, said ahollow elongate body head defining a rigid circular arc; said hollowelongate body head comprising a surgical needle adapted move along saidhollow elongate body head and through an orifice in said hollow elongatebody head to tunnel through a bone along a path formed by said rigidcircular arc; and,

an extendable and retractable support element, reconfigurable from atleast one extended configuration to at least one retractedconfiguration;

said support element, in said extended configuration is adapted to belocated along said path formed by said rigid circular arc; said supportelement, in said extended configuration, and said hollow elongate bodyhead are adapted to grasp said bone from at least two points along thecircumference of said bone;

a stabilizing element reconfigurable from at least one extendedconfiguration to at least one retracted configuration; wherein saidstabilizing element in said extended configuration, is adapted to be inphysical contact with said bone so as to fixate the orientation of saidcircular bone tunneling device relative to said bone.

It is within the core essence of the present invention where saidstabilizing element is adapted to reciprocally move along the mainlongitudinal axis of said circular bone tunneling device so as to bereconfigured from said extended configuration to said retractedconfiguration and vice versa.

It is within the core essence of the present invention where saidstabilizing element is pivotally coupled, at a pivot point, to thedistal end of said hollow elongate body at a pivot point of saidcircular bone tunneling device.

It is within the core essence of the present invention where saidstabilizing element is adapted to radially and pivotably rotate aroundsaid pivot point so as to be reconfigured from said extendedconfiguration to said retracted configuration and vice versa.

It is within the core essence of the present invention where saidstabilizing element in said extended configuration is adapted to beanchored within said bone.

It is within the core essence of the present invention where saidstabilizing element comprises a distal end and a proximal end; saiddistal end comprises a flange and a tip; said tip is adapted topenetrate said bone and to anchor said stabilizing element within thesame.

It is within the core essence of the present invention where said flangeis adapted to prevent the insertion of said proximal end of saidstabilizing element into said bone such that only said tip is anchoredwithin said bone.

It is within the core essence of the present invention where the shapeof said tip of said stabilizing element is selected from a groupconsisting of nail-like tip, screw-like tip and any combination thereof.

It is within the core essence of the present invention where said deviceadditionally comprising at least one suture cartridge comprising asuture; said suture is adapted to be passed through said circular arctunneled through said bone.

It is within the core essence of the present invention where saidsupport element, in said extended configuration is adapted to be locatedalong said path formed by said circular arc.

It is within the core essence of the present invention where saidsupport element, in said extended configuration, and said hollowelongate body are adapted to grasp said bone from at least two pointsalong the circumference of said bone.

It is another object of the present invention to provide the circularbone tunneling device as defined above, wherein said suture cartridgecomprising an external scaffold enclosing an inner body throughout whicha surgical tool is inserted.

It is another object of the present invention to provide the circularbone tunneling device as defined above, wherein said surgical tool isselected from a group consisting of grasper, tendon holder and anycombination thereof.

According to another embodiment of the present invention the surgicalneedle as defined above, is a rigid surgical needle.

According to another embodiment of the present invention the surgicalneedle's shape is slightly curved and approximately defines a circulararc.

The present invention also provides a method for tunneling through abone during arthroscopic surgery. The method comprises steps of:

(a) providing a curved bone tunneling device comprising:

-   -   a hollow elongate body comprising a hollow elongate body head,        said a hollow elongate body head defining a rigid circular arc;        said hollow elongate body head comprising a surgical needle        adapted move along said hollow elongate body head and through an        orifice in said hollow elongate body head to tunnel through a        bone along a path formed by said rigid circular arc;    -   an extendable and retractable support element, reconfigurable        from at least one extended configuration to at least one        retracted configuration; and,    -   a stabilizing element reconfigurable from at least one extended        configuration to at least one retracted configuration; wherein        said stabilizing element in said extended configuration, is        adapted to be in physical contact with said bone so as to fixate        the orientation of said circular bone tunneling device relative        to said bone;

(b) positioning said hollow elongate body of said device adjacent to thecircumference of a bone;

(c) fixating said needle to said bone;

(d) extending said retractable support element to a location along thepath formed by said circular arc; thereby grasping said bone with saidsupport element and said hollow elongate body at two points along thecircumference of said bone;

(e) extending said stabilizing element so as to reconfigure the samefrom said retracted configuration to said extended configuration;thereby fixating the orientation of said curved bone tunneling devicerelative to said bone;

(f) actuating said needle, thereby tunneling through said bone alongsaid circular arc path;

(g) inserting said needle into said support element once said needle hasbeen extracted out of said bone;

(h) loading said suture onto said needle; and,

(i) retracting said needle out of said bone; wherein said step oftunneling through said bone is performed without drilling.

As described above, the present invention provides an arthroscopic bonetunneling device which tunnels through an arc defined by two points onthe circumference of a bone. The tunnel is formed by penetration of aneedle device attached to a rigid hollow tube without the need to drill.

According to one embodiment, the arthroscopic bone tunneling device isconnected to a suture which is simultaneously passed through the tunnelso formed. The suture can then be used to fix a, tissue, muscle orligament to a bone tissue.

The arthroscopic bone tunneling device comprises, inter alia, a rigidhollow tube and which penetrates the bone at a first point along thecircumference of the same; and an extendable and retractable supportelement (will be disclosed hereinafter) which provides counter force ata second point along the circumference of the bone close to where thearc (i.e., the needle) exits the bone. Such an extendable andretractable support element enables the tunneling without drilling.

No anchors are required since the sutures are fixed to through the arcformed in the bone in a full loop configuration.

The extendable and retractable support (which provides the contra)device fixates the bone tunneling device onto the bone while tunnelingis being performed.

The entire unit has a low profile when entering the incision and aslightly larger profile when the fixation device is deployed.

Thus the unit is the first truly minimally invasive tool for rotary cuffrepair and does not require a large access incision and/or largesub-dermal space to deploy its streamline no drilling configuration.

The circular tunneler/adjustable suture passer of the present inventionis characterized by the following advantages:

(a) unlike most of the prior art devices, the circulartunneler/adjustable suture passer of the present invention performs nodrilling through the bone; alternatively the present invention tunnelsthrough the bone by applying consistent and sufficient force to a needleenabled by the force applied on the bone by the retractable supportelement as counter force to the force applied to the bone by the needle.

(b) the penetration through the bone is performed according to an arcshaped path (e.g. single bone entrance). Several known prior artpublications refer to the drilling of two orthogonal bores/channels soas to perform the arthroscopic surgery. As mentioned above, suchorthogonal bores are likely to cause fractures to the bone by weakeningthe same.

(c) the suture passer is adjustable. Due to the novel configuration ofthe device (namely, the extendable and retractable support element, aswill be disclosed hereinafter), the same can accommodate different bonediameters and different shapes and structures. In other words, thedevice of the present invention is adapted to various sizes, shapes andbone dimensions. The term “about” refers hereinafter to a range of 25%below or above the referred value.

As used herein, the term “needle” is understood to indicate any sharpinstrument used in medical practice to penetrate tissue. Thus, asnon-limiting examples, the term is understood to include suchinstruments as surgical needles and lances. It is also understood toinclude both hollow and solid instruments.

As used herein, the term “slip fit” refers to the mating of twomechanical components.

As used herein the term “ejecting” refers to an act of penetration ortunneling of an element through the bone without any drilling orremoving bone material (e.g. debris).

As used herein the term “adjustable” refers to the ability of thecircular bone tunneling device/suture passer to accommodate differentbone diameters and different shapes and structures.

As used herein the term “support” refers to maintaining the hollowelongate body head unit flush with bone surface by means of fixation ofthe unit to the bone circumference.

As used herein the term “fixation” refers to non-displacement of thehollow elongate body head and/or the surgical needle and/or the hollowtube when forces are being applied by the hollow tube driving mechanismand insures that the position of the hollow elongate body head and/orthe surgical needle and/or the hollow tube are maintained in the sameselected position.

Reference is now made to FIG. 1, which presents isometric drawings of apreferred embodiment 1000 of the invention herein disclosed. FIG. 1Apresents an external view of the circular bone tunnelingdevice/adjustable suture passer. A hollow elongate body forms the distalportion of the tool. The distal portion of the body comprises a hollowelongate body head 90 (referred hereinafter as head or hollow elongatebody head), which is curved downwards; as shown in the illustration, inpreferred embodiments, the head describes a rigid and an essentiallysemicircular arc, the concave side of the arc being on the underside.The proximal portion is a shaft 50. In preferred embodiments of theinvention, for ease of assembly the hollow elongate body is made fromtwo separate pieces 51 and 52 which are joined together in the finalstep of the assembly of the body and the components that are foundwithin. The body may be constructed of any suitable biocompatiblematerial such as a hard inert polymer or metal. The distal end of thehead contains an orifice through which a rigid circular hollow tube 34passes. The rigid circular hollow tube comprises at its distal end amechanism 30 by which connection can be made with an appropriately-sizedsurgical needle or lance 32, and is disposed within the head such thatit can move back and forth and extend a sufficient distance from the endof the head such that the needle or lance can describe an essentiallycircular path through a circle of diameter equal to that of the arcdescribed by the head. Means by which a surgical needle or lance can beattached to the end of the rigid circular hollow tube are well-known inthe art.

In order to stabilize the bone during extension of the needle so thatthe needle can enter the bone as it is protrudes from the tool, the toolfurther comprises an extendable and retractable support element 54 that,when extended, will grasp the bone on a second point along thecircumference of the bone, other that of the needle. The details of themechanism by which the support element is activated are given below.

The driving mechanism of the tool is housed within driving mechanismhousing 10 attached to the proximal end of the body. The control andmechanisms are located within the driving mechanism housing. A handle 12is attached to the underside of the tool, either to the body or to thedriving mechanism housing or to both. The movements of the hollow tooland the support element are controlled by independent control anddriving systems. In the view shown in FIG. 1A, some of the elements ofthese control and driving systems are visible. Rotatable handle 18 isconnected to the driving mechanism for the rigid circular hollow tubesuch that the motion of the distal end of the rigid circular hollow tubeis proportional to the angle through which the handle is turned.Activation of quick-release tab 20 causes the rigid circular hollow tubeto move directly to the end of its travel. Also visible in FIG. 1A aresome of the components of the support element driving system. Rotatableknob 14 is connected to the driving mechanism of the support elementsuch that the degree to which it is extended is proportional to theangle through which the knob is turned. Rotatable knob 18 comprises acentral threaded orifice that engages threaded rod 24; as the knob isturned, it moves down the length of the threaded rod. The controlmechanism also includes tab 22 which physically engages the drivingmechanism for the support element. The tab includes an orifice that fitsover the threaded rod distally to knob 14 and a stiff connector thatconnects the orifice to the distal end of the tab. The support elementcontrol mechanism also includes a quick-release pin 16, activation ofwhich enables the support element to move directly to the end of itstravel.

Reference is now made to FIGS. 67A-67B, which presents a view of theconnection between handle 12 and housing 10 one preferred embodiment ofthe invention. In this embodiment, the handle is attached to the housingvia sleeve 120 that surrounds the housing with a slip-fit sufficientlyloose to allow relative movement of the sleeve and the housing. Amechanism 121 allows the interior of the sleeve to be constricted, thusfixing the sleeve in place when it has been set in its desired location.Mechanism 121 also allows, when loosened, the handle to rotate freelyabout its own longitudinal axis, and when tightened, the angle ofrotation of the handle about its longitudinal axis to be fixed in place.Such mechanisms and means for activating them are well-known in the art.In these embodiments, the operator of the device can fix handle 12 inany desired location and orientation relative to the body of the device,and to change the relative location and orientation of the handle andthe body to one that is more comfortable, provides better leverage, etc.

Reference is now made to FIG. 67B illustrating one possible embodimentof mechanism 121. According to this specific embodiment, mechanism 121is a screw.

In some embodiments of the invention, it also includes means fordetermining how far the rigid circular hollow tube has traveled. In theembodiment illustrated in FIG. 1A, one side of the shaft includes awindow 512. The rigid circular hollow tube driving mechanism includes amark or other indicator 604 that is visible through the window andindicates the current position of the rigid circular hollow tuberelative to the bounds of its travel. A mark 514 is placed on the body;when indicator 604 reaches mark 514, the user knows that the rigidcircular hollow tube has reached the end of the travel.

Reference is now made to FIG. 69, which illustrates means fordetermining how far the rigid circular hollow tube has traveledaccording to other embodiments of the invention. In these embodiments,the device includes needle indicator 3200 and support indicator 5400.These indicators are designed to provide visual indications of theextent of travel of the needle and the rigid circular hollow tube,respectively. In the embodiment shown in FIG. 69A, the two indicatorsare colored tabs that ride in slots along the proximal-distal axis ofthe device. Needle indicator 3200 is in physical communication with theactuator for the needle, while support indicator 5400 is in physicalcommunication with actuator 58 for support element 54. In both cases,the distance through which the indicator has traveled is proportional tothe distance through which the corresponding component of the device hastraveled.

FIG. 69B illustrates the status of the two indicators prior to thebeginning of the procedure. Needle indicator 3200 is fully at one end ofits travel (fully forward in the embodiment illustrated), indicatingthat the hollow tube and therefore the needle is fully retracted.Likewise, support indicator 5400 is fully at one end of its travel(fully backward in the embodiment illustrated), indicating that thesupport element is fully retracted as well.

FIG. 69C illustrates the status of the two indicators after the supportelement has been extended, but while the needle remains fully retracted.Support indicator 5400 has now moved to the opposite end of its travel,while needle indicator 3200 remains in its initial position.

FIG. 69D illustrates the status of the two indicators after the needlehas passed through the tendon and the bone. Now, both indicators are atthe far end of their travel, indicating that the both the supportelement and the hollow tube are fully extended; full extension of thehollow tube indicates that the needle has passed through the bone andinto the needle catcher. When both indicators have moved to the far endof their travel, the surgeon thereby knows that it is now possible toexchange suture 130.

Reference is now made to FIG. 1B, which provides an isometric view ofembodiment 1000 after the left-hand side of the body 51 has been removedto reveal the interior of the hollow body. In this embodiment, thedriving mechanism for the rigid circular hollow tube comprises a seriesof slidable members (beads) attached to one another. The interior of thebody includes on its upper or lower side or both a track 522 that guidesthe movement of the slidable members. The distal slidable member 4 isflat on its forward side, which engages the proximal end of the hollowtube. The remaining slidable members 2 need not be flat on the forwardside; as described in detail below, in preferred embodiments, theypresent a substantially circular profile. In this embodiment, thedriving mechanism also includes at its proximal end rigid circularhollow tube actuator 6 that engages the rigid circular hollow tubecontrol such that when the rigid circular hollow tube control movesforward, it causes the activator to move forward, thereby causing theslidable members to slide distally, pushing the hollow tube.

Also visible in the view shown in FIG. 1B is the activating mechanismfor the support element. In this embodiment, the support elementactivating mechanism comprises an actuator 58 that engages at itsproximal end the distal end of the support element control, and at itsdistal end support element connecting yoke 56 whereby forward movementof the support element control forces forward movement of actuator 58(along axis 582) and hence forward movement of connecting yoke 56. Theconnecting yoke is pivotally connected to the support element via pivotelement (e.g. a pin around which the assembly can rotate) 562. Whenactivated, the support element moves along axis 542. It should beemphasized that the distal end of the support element, when activated,is located along the path formed by the rigid circular arc.

According to another embodiment, a circular cross section/profile of theshaft is provided. According to this embodiment, the circular profileensures the best adhering/joining of the two parts of the incision(through which the circular tunneler/suture passer is being inserted).Such profile significantly reduces any leakage (of e.g. saline, which istypically used by surgeons to expand the inner volume) that may bedeveloped during the operation.

The rigid circular hollow tube driving mechanism described above canprovide a force of several hundred Newtons (especially, in the range ofabout 500 to about 600 Newton) to the hollow tube, which is more thansufficient for the rigid circular hollow tube to penetrate bone.

In order to insure that the protruding needle actually penetrates thebone rather than displacing the hollow elongate body head away from thebone surface, support must be provided to maintain the hollow elongatebody head unit flush with bone surface by means of fixation of the unitto the bone circumference opposite to the side through which the needleenters. Hence, the tool comprises an extendable/retractable supportelement which, when extracted, extends from the underside of the toolopposite to the head. Reference is now made to FIGS. 2A and 2B, whichshow embodiment 1000 of the tool after the support element 54 has beenextended. In preferred embodiments of the invention, the support elementadditionally comprises a needle extractor 60.

The needle extractor 60 is responsible for maintaining penetratingelement 32 within the support element 54. The same is enabled by meansof a bore 601 located within the penetrating element 32, into which theneedle extractor 60 penetrates so as to prevent the departure ofpenetrating element 32 from the support element 54.

Penetrating element 32 is a sharp element that can be pushed into thebone and penetrate through it. Penetrating element 32 pulls wire 130with it (130 is connected to the proximal end of 60).

Once a full arc path from circumference point 1 to circumference point 2through the bone has been formed, needle extractor 60 remains within thebore 601 [while the arched rigid hollow tube 34 returns back to housing90.

Needle extractor 60 enables the penetrating element 32 to enter intosupport element 54 yet, ensures its release from the rigid circularhollow tube 34 when the same moved reversibly back into head.

Needle extractor 60 is an elastic element, bendable in one direction yetstiff in the opposite direction. Embodiment 1000 (illustrated in FIG. 1)discloses needle extractor 60 as a rigid hook rotating on an axis with atorsion spring pushing it.

It should be understood that several other embodiments may be utilized,however. For example, the mechanical properties of the needle extractor60 (namely, its elasticity and spring-like properties) can be exploited.

Reference is now made to FIGS. 2C and 2D, which illustrate an embodimentin which the spring-like properties of the needle extractor 60 isutilized.

In such an embodiment, the needle extractor 60 may be integrated intosupport element's 54 internal surface. According to this embodiment, theneedle extractor 60 is characterized by two configurations, an extendedconfiguration and a retracted configuration.

In the extended configuration, the needle extractor 60 substantiallyreduces the inner diameter of support element 54; and, in the retractedconfiguration of the needle extractor 60, the inner diameter of supportelement 54 remains substantially the same.

Due to the needle extractor's 60 spring-like properties, it can bereconfigured from the extracted configuration to the retractedconfiguration by application of force on the same. Once no force isapplied, the needle extractor 60 is reconfigured back from the retractedconfiguration to the extended configuration.

The default configuration of the needle extractor 60, according to thisembodiment is the extended configuration, in which the inner diameter ofsupport element 54 is reduced.

Once the penetrating element 32 enters the support element 54, theneedle extractor 60 is reconfigured from the extended configuration tothe retracted configuration and applies pressure on the penetratingelement 32, so as to maintain the same within support element 54.

It should be emphasized that the support element 54 may comprise eitherone or a plurality of said needle extractors 60.

Reference is now made to FIG. 2D which illustrates the above mentionedembodiment, but with the penetrating element 32 integrated within thesupport element 54.

FIG. 2B illustrates a close up view of how the needle extractor 60functions once penetrating element (e.g., needle or lance) 32 are withinthe support element 54 and after the rigid circular hollow tube 34 isdrawn back.

It should be noted that the distal face of element 54 is equipped withprongs 62, adapted to prevent any movement of the support element 54,once the same is positioned at desired location.

In preferred embodiments, the needle extractor is disposed on theunderside of the support element and comprises a hollow receptacle intowhich the penetrating element (needle or lance) 32 enters upon reachingcircumference point 2.

When either the support element or the rigid circular hollow tube isretracted following use of the tool, the penetrating element remainswithin hollow receptacle of the needle extractor 60.

Reference is now made to FIG. 3, which shows a cross-sectional view ofembodiment 1000 of the tool after the rigid circular hollow tube hascompleted its travel. A guide wire 130 passes through the rigid circularhollow tube and is attached to the proximal end of the lance 32 (whichin this view has passed through the bone, shown as a shaded region inthe figure).

A suture can then be attached to the distal end of the guide wire andpassed through the soft tissue and into and through the bone. In theview shown in FIG. 3, the needle has entered into the needle extractor60.

Reference is now made to FIG. 4, which shows a cross-sectional view ofthe tool after the support element has been retracted. In this view, therigid circular hollow tube is still within the bone, and needle can beseen to have remained within the needle extractor, carrying guide wire130 with it.

A cavity in retractable support element 54 provides a ‘nesting volume’for the penetrating element 32 securing it to its position, so as toprevent any damage to surrounding tissues.

Reference is now made to FIGS. 5A-5D, which illustrate the distal end ofanother preferred embodiment of the tool. According to this embodiment,an additional radial support is provided to rigid circular hollow tube34 sections that aren't yet within the bone in order to ensure that atthe end of its travel it will engage needle extractor 60.

In this embodiment, the support element further comprises a tab 5421that protrudes through a slot 5422 in one side of the head (90).

Tab 5421 slides in a slot 5422 so as to indicate the current position ofthe rigid circular hollow tube relative to the bounds of its travel.

Most significantly, this embodiment further includes rigid supportelement 70. The support element is located between the right and lefthalves of the head; in a preferred embodiment of the device, the headand body are manufactured from two matching pieces that form the leftand right halves of the device when it has been assembled.

FIG. 5A shows an external view of head 90, including rigid supportelement 70. The same illustrating how it sits between the two halves ofthe head.

FIG. 5B shows a partial cutaway view of the head with support element 70in place. An isometric view of rigid support element 70 can be seen inFIG. 5C. Support element 70 has the shape of an arc with essentially thesame curvature as the upper portion of head 90. Slots on either side ofthe support element hold it in place between the two halves of the headwhen it is assembled. Support element 70 has a depth sufficient tocontact rigid circular hollow tube 34 while not hindering the movementof the hollow tube. Rigid support element thus provides additionalsupport to rigid circular hollow tube 34 and prevents it from bending orcrimping (and any other deformation) such that the rigid circular hollowtube is constrained to move only along a path that will return it toneedle catcher 60, as shown in FIG. 5D and FIG. 6D.

Reference is now made to FIG. 6A, which illustrates a preferredembodiment of slidable member 2. In preferred embodiments, the slidablemember is substantially cylindrical in shape, with an indentation 204around the waist of the cylinder (i.e. around its circumference andperpendicular to the cylinder's longitudinal axis). The indentationallows guide wire 130 to pass unhindered. At least one of the ends 202fits into track 522 that enables the member to slide along thedistal-proximal axis of the body. Note that even though the member has acircular cross-section, it does not roll along the track.

A channel 206 passes through the slidable member along an axissubstantially perpendicular to the longitudinal axis of the cylinder. Aconnecting wire 132, disposed along the proximal-distal axis of thebody, passes through the channel, thereby connecting the plurality ofslidable members. The connecting wire is formed into a loop, theproximal end of which engages the rigid circular hollow tube drivingmechanism, enabling the rigid circular hollow tube to be retracted afterthe tool has been used. As shown in the figure, as with guide wire 130the leg of the loop in connecting wire 132 that does not pass throughthe channel passes outside the slidable member via indentation 204.

Reference is now made to FIG. 6B, which illustrates a preferredembodiment of distal slidable member 4. The overall cylindrical shape402, indentation 404, and channel 406 are analogous to components 202,204, and 206 of slidable member 2 illustrated in FIG. 5A. Unlike theother slidable members, the distal slidable member directlyengages/actuates rigid circular hollow tube 34. Thus, it is providedwith a flat face 410 that is oriented facing forward (i.e. in thedirection of motion toward head 90), and a channel 408 that fits overthe proximal end of rigid circular hollow tube 34 and, in preferredembodiments, is physically connected thereto.

In embodiments of the invention that incorporate rigid support member70, slidable members 2 have a somewhat different configuration from thatshown in FIG. 6A. The configuration of slidable member 2 in theseembodiments is shown in FIG. 6C. While the slidable member retains itsgenerally cylindrical shape, the indentation is no longer symmetricalabout the axis of the cylinder. Rather, indentation 2004 is cut throughmost of the diameter of the cylinder so that the slidable member 2 maypass under support element 70. Consequently, channel 2006 adapted toallow passage of connecting wire 132 is displaced from the center, asshown in the diagram. A second indentation 2008 is made on the oppositeside of the member to allow passage of guide wire 130. One side of thecylinder (2002) is adapted to slide on track 522. A schematic assemblydiagram showing support member 70, slidable member 2, and rigid circularhollow tube 34 in its extended position (i.e. after the needle attachedto it has reached needle catcher 60), is given in FIG. 6D.

Reference is now made to FIG. 7, which presents a cross-sectional viewof the assembly of the rigid circular hollow tube driving mechanismaccording to one embodiment of the invention. The slidable members areconnected via connecting wire 132 through orifices 206 and 406 to form atrain. Connecting wire 132 loops back through indentations 204 and 404;the proximal end of the loop engages the rigid circular hollow tubecontrol such that when the rigid circular hollow tube control isactivated, the slidable members move in tandem, thereby moving the rigidcircular hollow tube 34 and the needle or lance 32 connected to itsdistal end. Guide wire 130 passes through indentations 204 and 404,whereby motion of the guide wire, which as described above passesthrough the rigid circular hollow tube 34 and is connected to needle orlance 32, is unimpeded.

Reference is now made to FIG. 8, which presents isometric views of thehollow tube (driving mechanism) control according to a preferredembodiment of the invention.

The control mechanism is disposed within and about driving mechanismhousing 10. Rotatable knob 18 comprises a substantially circular handle(in preferred embodiments, it is knurled or its circumference isprovided with a plurality of indentations or protrusions for ease ofhandling) and a hollow shaft 186 the internal wall of which is threaded.Driving mechanism housing 10 comprises a channel of internal diameterappropriate to provide a slip fit to hollow shaft 186 and a distal wallwith an orifice through which hollow tube actuator 6 passes. Thethreaded shaft further comprises a groove 182 around the circumferenceof its external wall, substantially perpendicular to the longitudinalaxis of the shaft, and disposed substantially at its distal end. Thethreaded hollow shaft engages a threaded rod 602 which is physicallyconnected to the proximal end of hollow tube actuator 6. A hollow tubedriving mechanism release tab 20 is pivotably connected to the body ofdriving mechanism housing 10. The hollow tube driving mechanism releasetab comprises two protrusions extending from the central pivoting body,one of which (212) engages groove 182 and one of which extends abovedriving mechanism housing 10 used for handling.

FIG. 8A shows a view of the hollow tube control as it appears when thedriving mechanism release tab 20 is in its engaged position. In thisconfiguration, protrusion 212 prevents handle 18 from moving along thedistal-proximal axis of the body, so rotation of the handle causesthreaded rod 602 to travel along the length of the shaft, therebydriving hollow tube actuator 6 and, via the remainder of the hollow tubedriving mechanism (not shown in FIG. 8) engaged by actuator 6, slidablemember (e.g., 2 and 4) and hollow tube 34 such that the distance throughwhich the hollow tube moves is proportional to the angle through whichknob 18 is rotated. In FIG. 8A, the threaded rod is shown at the mostdistal point of its travel; further movement of the threaded rod isblocked by the distal wall of driving mechanisms housing 10.

Application of pressure to its external protrusion activates tab 20,moving protrusion 212 to its disengaged position. FIG. 8B shows thehollow tube control with tab 20 in its disengaged position. Since inthis configuration motion of knob 18 along the distal-proximal axis ofthe tool is unhindered, it is possible in this case to move hollow tube34 by pushing or pulling knob 18 without turning it. By pulling knob 18to the proximal direction hollow tube 34 is retrieved back into 90.

Reference is now made to FIG. 9, which presents isometric viewsillustrating the support element control according to a preferredembodiment of the invention. FIG. 9A shows an external view, while FIGS.9B and 9C illustrated the internal mechanism of the support elementcontrol with handle 12 removed. In the embodiment of the support elementcontrol illustrated in FIG. 9, it comprises a threaded rod 24 and aquick-release pin 16. Quick-release pin 16 is adapted such that when itis in its disengaged position (as in FIG. 9B), motion of the threadedrod (both axial and rotational) is blocked, while when it is in itsengaged position (as in FIG. 9C), motion of the threaded rod ispermitted.

The support element control further comprises rotatable knob 14, whichcomprises an internally-threaded orifice that engages the threads ofthreaded rod 24. As with rotatable knob 18, in the most preferredembodiments, the circumference of knob 14 is knurled or provided with aplurality of indentations or protrusions for ease of handling. Thecontrol also comprises a slider, which comprises a tab 22, a circularorifice 26 of internal diameter at least sufficient to provide a slipfit over threaded rod 24, and a rigid connector that attaches theorifice to the tab. Tab 22 comprises a portion 27 that slides along theunderside of shaft 50 and a protrusion that extends below the shaft. Thedistal portion of In some embodiments of the circulartunneler/adjustable suture passer that comprise this embodiment of thesupport element control, the underside of shaft 50 comprises a slot thatallows the protrusion to move freely along the proximal-distal axis ofshaft 50; in other embodiments, shaft 50 comprises a track on theexterior of its underside in which tab 22 and those portions of thesupport element driving mechanism engaged thereby slide.

In the embodiment of the support element control illustrated in FIG. 9,it engages the support element driving mechanism as follows. As knob 14is turned, it travels along the length of threaded rod 24. When thetravel is in the distal direction, the knob will engage orifice 26,thereby causing tab 22 to move in the distal direction. As slidingportion 27 moves distally, it engages the proximal end of the supportelement driving mechanism (e.g. actuator 58), thereby causing thesupport element to extend. When the user wishes to retract the supportelement, knob 14 is turned in the opposite direction, causing it totravel proximally along threaded rod 24. This motion will then leave agap between knob 14 and orifice 26. Tab 22 can then be moved in theproximal direction manually by application of pressure to the portionthat extends beneath shaft 50.

As shown in FIG. 9B, when quick-release pin 16 is in its engagedposition, it prevents threaded rod 24 from moving, either by physicallyholding it (e.g. via a retractable vise-like grip) or by engaging anindentation in the threaded rod. When pin 16 is disengaged, as shown inFIG. 9C, it no longer prevents movement of threaded rod 24. In a manneranalogous to that of driving mechanism release tab 20, engagement of thequick-release pin permits the user to manually move the support elementcontrol without the necessity of turning knob 14.

Reference is now made to FIG. 10, which shows a view of a secondembodiment 2000 of the circular tunneler/adjustable suture passer hereindisclosed. The embodiment shown in FIG. 10 incorporates additionalembodiments of the hollow tube and support element driving mechanismsand of the support element driving mechanism.

In the embodiment of the hollow tube driving mechanism shown in FIG. 10,shaft 50 incorporates body slot 330 along at least part of the length ofat least one side of the body, and head 90 incorporates head slot 390along at least part of the length of at least one side of the head.Slider 310 engages the hollow tube control at its proximal end. Yoke 300is pivotably connected to slider 310 by pin 320 that passes through bodyslot 330, and is pivotably connected to the proximal end of hollow tube34 by pin 324 that passes through head slot 390. When the hollow tubecontrol is engaged, pin 320 travels distally, whereby yoke 300 forceshollow tube 34 to travel distally in proportion to the distance throughwhich slider 310 has traveled. In this embodiment, the hollow tubecontrol further comprises bearing housing 380.

FIG. 10 also shows a second embodiment of the support element drivingmechanism. In this embodiment, the support element driving mechanismcomprises an actuator 58 that engages at its proximal end the supportelement control and that is pivotably connected substantially at itsdistal end to a yoke 340 via a pin (not shown in FIG. 10). Yoke 340 ispivotably connected substantially at its distal end to the supportelement. When the support element control is engaged, actuator 58travels distally, whereby yoke 340 moves downward, causing the supportelement to extend. In the embodiment shown in FIG. 10, handle 12comprises two portions, a movable distal portion 12A and a stationaryproximal portion 12B. In the embodiment shown, the handle is designedsuch that the user can grip it by placing his or her fingers throughorifices at the bottom of the two portions of the handle. The movabledistal portion of the handle further comprises a tab that fits into aslot in the underside of shaft 50.

In this embodiment, the support element control comprises the movableportion of the handle, which engages actuator 58; in preferredembodiments, the two are physically connected. As the movable portion ofthe handle is moved, actuator 58 moves in tandem, forcing yoke 340 tomove and thereby extending or retracting the support element.

Reference is now made to FIG. 11, which shows views of the interior ofthe distal end of the circular tunneler/adjustable suture passeraccording to this second embodiment of the invention. The view shown inFIG. 11A illustrates how guide wire 130 passes through the head andshaft, and how the hollow tube actuator 58 engages yoke 340. FIG. 11Billustrates the workings of the support element driving mechanismaccording to this embodiment of the invention. When actuator 58 (shownin FIG. 11A, not shown in FIG. 1B) moves distally, it engages yoke 340.Substantially at its distal end, the yoke is connected to supportelement 54 via bearing 332. As the yoke descends in tandem with themotion of the actuator, the support element is pulled downward andforward, thus extending into its working position.

In the embodiments described thus far, the actuation of the device isperformed manually. Reference is now made to FIG. 12, which presents aschematic illustration of an embodiment in which the hollow tube controland support mechanism control are actuated electrically. Motor 700engages at least one of rotatable knobs 14 and 18. In the embodimentshown in the figure, each of the two rotatable knobs is engaged by amotor; motor 700A engages rotatable knob 14 and motor 700B engagesrotatable knob 18. Any type of motor known in the art appropriate foractuating a medical device may be used. In preferred embodiments of theinvention, motors 700A and 700B are DC stepper motors. FIG. 12A shows anoverall schematic of such an embodiment. FIG. 12B presents a closer viewof the hollow tube and support element controls. In these embodiments,rather than a knurled nut, each rotatable knob comprises a gear 720(720A and 720B). Motors 700 (700A and 700B) drives gear 710 (710A and710B, respectfully), which in turn drives gear 720 (720A and 710B,respectfully). FIG. 12C presents a cutaway view of the two rotatableknobs, illustrating the internal threads of the knobs and the threadedrods that the knobs engage, showing how the motor actuates the controlmechanisms. Said gearing elements basically transform the motor'srotational input into two axial, linear, independent and juxtaposedmoves.

In some embodiments of the invention, it further comprises a tendonholder. Any tendon holder known in the art that can be adapted for usewith the present invention may be used.

The term “tendon holder” refers hereinafter to any device which enablesthe grasping of a tendon and pass of a suture through the same.

Reference is now made to FIG. 13, which illustrates a preferredembodiment of a tendon holder especially adapted for use with theinvention herein disclosed. FIG. 13A presents a view of the distalportion of the circular bone tunneling device/suture passer showing thetendon holder. The tendon holder comprises grasping member 800, slider810, and manipulator 820.

According to another embodiment, the tendon holder may comprise a singlemanipulator that enables both pushing and/or pulling movements.

The slider is attached to the hollow elongate body of the circulartunneler/suture passer such that it can slide back and forth along thebody. For example, it can comprise a channel with internal dimensionschosen to provide a slip fit over the body. Manipulator 820 is attachedto the proximal side of the slider and sits on the upper side of thebody. As can be seen in the diagram, in preferred embodiments, themanipulator has an ergonomic shape such that it can be pushed and pulledby the thumb of the operator of the device. Grasping member 800 isattached to the distal side of the slider. It is disposed on the upperside of the elongate body and slides along the distal-proximal axis ofthe body on the upper side of the body and passes under the head at thepoint at which the head is attached to the body. As can be seen in thediagram, in preferred embodiments, it has an elongated shape (e.g. aparallelepiped that is wider than it is high) and has a lengthsufficient that when it is moved to the distal end of its travel, itreaches sufficiently close to the distal end of head 90 that a tendoncan be grasped between the distal end of the grasping member and theunderside of the head. In the most preferred embodiments, when thegrasping member is retracted to the most proximal point of its travel,it does not extend beyond the end of the body of the circular bonetunneling device/suture passer. An overall view of an embodiment 3000 ofthe device that comprises a tendon holder is shown in FIG. 13B.

It is also within the scope of the invention to disclose a method fortunneling through a bone during arthroscopic surgery. The methodcomprises steps of (a) providing a curved bone tunneling devicecomprising: (i) a hollow elongated body defining a rigid circular arc;said hollow elongated body comprising a surgical needle adapted totunnel through a bone along a path formed by said circular arc; and,(ii) an extendable and retractable support element, reconfigurable fromat least one extended configuration to at least one retractedconfiguration; (b) positioning said hollow elongated body of said deviceadjacent to the circumference of a bone; (c) fixating said needle tosaid bone; (d) extending said retractable support element to a locationalong the path formed by said circular arc; thereby grasping said bonewith said support element and said hollow elongated body at two pointsalong the circumference of said bone; (e) actuating said hollow tube andsaid needle, thereby tunneling through said bone along said circular arcpath; wherein said step of tunneling through said bone is performedwithout drilling.

It is also within the scope of the invention to disclose a method forattaching soft tissue such as a ligament to a bone without the use of ananchor. The method comprises the following steps. A guide wire is passedthrough a device capable of imparting sufficient force to a surgicalneedle such that the surgical needle will pass through bone. A surgicalneedle or lance is attached to the guide wire and then connected to thedistal end of the device. The device is then inserted into position. Asupport element engages the bone through which the needle is to beinserted on a side of the bone opposite that into which the needle is tobe engaged, i.e. it holds the bone from the side towards which it wouldtend to move when the needle hits the bone's surface. The device is thenengaged, causing the needle (and the guide wire attached thereto) topass through the bone. A suture is attached to the proximal end of theguide wire. The guide wire is pulled through the bone, carrying thesuture with it. Once the suture has passed through the bone, the guidewire is detached and discarded.

Reference is now made to FIG. 14 which illustrates an embodiment inwhich the decoupling of the shaft (50) is enabled.

In other words, FIG. 14 presents a schematic view of a connector forrapid connection and disconnection of the shaft. Such a connector isparticularly useful for embodiments that comprise motorized control.

In some embodiments of the invention in which it the circular bonetunneling device mechanically driven by one or more motors, it mayinclude a connector for rapid connection and disconnection of theworking portion of the circular bone tunneling device/suture passer(i.e. the head and the elongate body) from the shaft that contains thehollow tube and support mechanism controls.

Reference is now made again to FIG. 14, which illustrates an example ofsuch a connector. The connector is hollow to allow physical connectionof the control and driving mechanisms within the same, and comprises atleast one pivotable joint 900. The pivotable joint 900 comprises a slot,a fixed acceptor 910 with a pin adapted to match the slot, and aslidable closure 920 that slides over the joint and pin after theconnection is made (so as to fix the connection).

It should be understood to one skilled in the art that the design (e.g.,cross section, length et cetera) and properties (e.g., mechanicalproperties; rigid or soft) of the surgical needle used is of criticalimportance in order to successfully enable the penetration of the needleinto the bone.

As mentioned above, one of the needle's critical properties is thelength of the needle used. If the needle used is too long, changing thedirection of the penetration path by the hollow tube would be resistedand difficult to achieve.

According to another embodiment, the needle is a straight needle orslightly curved needle. According to another embodiment of the presentinvention the cross sectional area of the needle is selected from agroup consisting of circular, triangular, rectangular, flat, or anycombination thereof. Reference is now made to FIG. 66, which presentsthree views (side, top, and isometric) of a flat needle 32 as used insome embodiments of the invention.

It should be understood to one skilled in the art that the design (e.g.,cross section, length et cetera) and properties (e.g., mechanicalproperties; rigid or soft, materials from which the same is made) of thesurgical rigid hollow tube used is of critical importance in order tosuccessfully enable the penetration of the same into the bone.

According to one embodiment of the present invention, the hollow tube'souter diameter is in the range of about 1 to about 3 mm; According toanother embodiment, the internal diameter (through which the guide wirepasses) is in the range of about 0.5 to about 1.5 mm; or any combinationthereof. Reference is now made to FIG. 17 illustrating both the internaldiameter (illustrated as numerical reference 1701) of the hollow tubeand the outer diameter (illustrated as numerical reference 1702) of thesame. Also illustrated in the figure is the radius of curvature(illustrated as numerical reference 1703). According to one embodimentof the present invention the radius of curvature 1703 is in the range ofabout 7.5 mm to about 15 mm, especially 12.5 mm. According to anotherembodiment, the surgical rigid hollow tube is made of biocompatiblemetal selected from hardened corrosion resistant steel.

Reference is now made to FIG. 15A illustrating a hollow tube 34 having atriangular cross-section.

It should be pointed out that according to one embodiment of the presentinvention wire 130 is threaded through the hollow tube 34. According toanother embodiment, the hollow tube 34 and the surgical needle comprisesa groove along said needle's circumference (incase the cross section ofsaid hollow tube is circular) or along at least one of said hollowtube's rib (in case the cross section is triangular or rectangular)throughout which said wire 130 is threaded. It should be understood toone skilled in the art, that the formation of a groove along one of thecircumference or ribs simplifies the production line of the same.Reference is now made to FIG. 15b illustrating such an embodiment.According to this embodiment wire 130 is along groove 1500.

According to one embodiment of the present invention, one of thetriangle's vertexes is pointing towards the center of the circular arc.Such an embodiment will ensure minimal resistance during the penetrationinto the bone.

Reference is now made to FIGS. 16A-16B, illustrating another embodimentof the present invention in which the needle 32 being used is a slightlycurved needle. Such curved needle ensures the mating and the slip fitbetween the needle, 32, and the support element 54 and further allowsthe needle and hollow tube to move in the direction of the arc.

FIG. 16B also illustrates an embodiment in which the hollow tube 34comprises a grove 1500 along which said wire 130 is threaded.

It should be understood to one skilled in the art that the design (e.g.,cross section, length et cetera) and properties (e.g., mechanicalproperties; rigid or soft, materials from which the same is made) of thesurgical rigid hollow tube used is of critical.

Reference is now made to FIGS. 18-20 which illustrate another embodimentof the extendable/retractable support element (54).

According to this embodiment, the support element (54) is movable alongthe rigid circular arc formed by the hollow elongate body.

In this embodiment, the support element driving mechanism comprises anactuator 58 that is pivotably connected substantially at its distal endto a yoke 340 via a pin 341. Yoke 340 is pivotably connectedsubstantially at its distal end to the support element 54. When actuator58 is engaged, the same travels distally, whereby yoke 340 movesdownward, causing the support element 54 to extend downwardly along therigid circular arc formed by the hollow elongate body.

Reference is now made to FIG. 19 which illustrates the support element54 when the same is fully extended.

As can been seen from FIG. 19, actuator 58 has traveled its full pathdistally, thereby causing yoke 340 and support element 54 to fullyextend downwardly.

According to this embodiment, an arch-like shaft 342 is coupled to thehollow elongate body head 90 from the underside of the same, such thatwhen the support element 54 is activated, the same slides along thearch-like shaft 342.

Said slide of the support element 54 along said arch-like shaft 342reconfigure the support element 54 from the retracted configuration tothe extended configuration.

Reference is now made to FIG. 20, which, as in FIGS. 18-19, illustratesthe new embodiment of the support element 54, when the same is partiallyextended.

Reference is now made to FIGS. 21-31 illustrating a second embodiment ofthe circular bone tunneling device/adjustable suture passer.

According to this embodiment, a suture cartridge 500 is provided. Saidsuture cartridge 500 loads a suture to the support element 54 such thatwhen the needle 32 engages with the support element 54, the same‘catches’ the suture.

It should be pointed out that the term “engagement of the needle withthe support element” refers hereinafter to the entrance of the needle 32into the support element 54 once the needle has emerged out of the boneafter tunneling the arc-shaped path through the same.

It should be pointed out that the term “catches” refers hereinafter toany means (either by mechanical means, magnetically, electrical means orany combination thereof) adapted to capture or hold the suture.Specifically the term catches refers hereinafter means provided with/onthe needle 32 adapted to catch the suture when the same engages with thesupport element.

Said circular bone tunneling device, unlike the previously disclosedembodiment, comprises a dedicated suture 32 (will be disclosed in FIGS.21-22), a suture cartridge 500 (will be disclosed in FIGS. 23-26) and aloading mechanism for loading the suture 130 onto the support element 54(will be disclosed in FIGS. 27a-27e ).

Reference is now made to FIGS. 21-22 which illustrate another embodimentof the needle 32.

According to this embodiment, needle 32 comprises at least one hook 321.Said hook's 321 role is in the engagement of the needle with the supportmember so as to catch the suture/wire 130 (will be disclosedhereinafter).

Reference is now made to FIG. 22 illustrating the fully extended supportmember 54 and needle 32 engaging with the same (i.e., the needle isfully inserted into said support member 54). In this stage, the hook 321will catch the suture.

Reference is now made to FIGS. 23-26 illustrating the suture cartridge500.

Suture cartridge 500 is coupled to shaft 50 of the circular bonetunneling device (see FIG. 26), and is adapted to reciprocally movealong the longitudinal axis of the same so as to load the suture 130onto the support element 54 (as will be disclosed hereinafter).

The cartridge 500 is characterized by having an external scaffold 501enclosing an inner body 502 (see FIG. 25). Said inner body plays animportant role and enables the insertion of a working tool throughoutthe same (as will be disclosed hereinafter).

According to this embodiment, suture 130 is disposed along the outercircumference of scaffold 501 of cartridge 500.

Reference is now made to FIGS. 27A-27E illustrating the loadingmechanism 600 for loading suture 130 onto the support element 54.

The loading mechanism 600 comprising at least one (preferably two) hooks603 pivotably connected to the support element 54.

In order to load suture 130 to the supporting element 54, suturecartridge 500 is linearly moved forward towards the supporting element54 (see FIG. 27A), until suture 130 reaches hooks 603.

FIGS. 27B-27D provides a closer view of the suture loading mechanism.

First, the suture cartridge 500 is pushed forwards (see FIG. 27B) untilsuture 130 reaches hooks 603 of the support element 54 (see FIG. 27C).

Next, the suture is passed over hooks 603 such that the hooks holdsuture 130 (see FIGS. 27D-27E) and prevent its release. Said suturebeing held by hooks 603 will be later engaged with the needle 32 (morespecifically with hook 321 of the needle).

Reference is now made to FIGS. 28-31 which illustrates the engagement ofthe needle 32 with the support element 54 and the suture cartridge 500(after the suture 130 has been loaded).

FIG. 28 illustrates the circular bone tunneling device once the suture130 has been loaded to the support element 54 and the needle has alreadypenetrated into the bone 1000 and tunneled through the same.

FIG. 29 illustrates needle 32 engaging with the support element 54. Themain objective of said engagement is to ‘catch’ suture 130. Saidcatching is provided by means of hook 321.

Once said hook 321 reaches suture 130 being held by hooks 603 of thesupporting element 54, the same encases suture 130.

Once said hook 321 catches suture 130 needle 32 can be retracted backthrough bone 1000 (along the circular path created/tunneled by saidneedle 32 when the same penetrated said bone 1000), see FIGS. 30-31.

According to another embodiment of the present invention the catching ofthe suture is provided by at least one selected from a group consistingof electrical means, magnetic means or any combination thereof beingprovided along/within/with said needle 32.

Furthermore, it should be understood that the hook 321 disclosed aboveprovided along said needle is given as a mere example of mechanicalmeans capturing the suture. Other embodiments as known in the art can beapplied as well.

According to another embodiment of the present invention, a working toolis provided along a working channel within the circular bone tunnelingdevice.

According to one embodiment the inner body 502 of suture cartridge 500is utilized as the working channel.

As mentioned above, the suture cartridge comprises an inner body 502.Said inner body 502 is structured to have a diameter of approximately 3mm such that any surgical tool having a diameter of 3 mm or less couldbe inserted through the same. Such tool could be e.g., grasper, tendonholder, scissors, diathermy means, scalpel, stapler, jig, suturing meansand any combination thereof.

According to another embodiment of the present invention the workingtool (e.g., grasper) can be passed through the shaft 50 of the circularbone tunneling device.

Reference is now made to FIGS. 32-34 illustrating such an embodiment.According to said embodiment, shaft 50 is structured to have an innerelongated hollow tube (will be referred hereinafter as a workingchannel) 503 running throughout shaft 50 (see FIG. 32).

According to another embodiment the inner body 502 of cartridge 500 isutilized as the working channel (see FIG. 33).

FIG. 34 illustrates the incorporation of a working tool (e.g., grasper)1001 into the circular bone tunneling device.

Reference is now made to FIGS. 35-49 illustrating the overall method ofutilizing the circular bone tunneling device.

FIG. 35 illustrates the grasper being inserted through the workingchannel 503 of the circular bone tunneling device (e.g., through theinternal body 502 of the cartridge 500).

FIG. 36 illustrates the grasping of the tendon 1002 by means of thegrasper 1001.

FIG. 37 illustrates grasper 1001 pulling the tendon 1002 to a positionat which the needle 32 will penetrate. FIGS. 38-39 illustrate a closerview of the same.

FIG. 40 provides a closer view of the needle being extracted from thecircular bone tunneling device (namely from the hollow elongate bodyhead 90.

FIG. 41 illustrates the needle 32 being passed through the tendon 1002.

FIG. 42 illustrates the grasper 1001 being removed and extracted fromthe circular bone tunneling device.

FIG. 43 illustrated the support element 54 being fully extended (afterthe suture 130 has been loaded, not shown). FIG. 44 provides a closerview of the same.

FIG. 45 illustrates the needle 32 being pushed forward through the bone1000 so as to create said curved tunnel through the same.

FIG. 46 illustrates the engagement of needle 32 with the supportingelement 54. As described above, hook 321 of needle 32 engages with hooks603 of support member 54 and encase suture 130.

FIG. 47 illustrates needle 32 being retracted (moved back) through thecurved channel with suture 130 caught onto hook 321.

FIG. 48 illustrates the needle 32 being fully extracted from bone 1000.

FIG. 49 illustrates the needle 32 and the supporting element 54 beingretracted back to the circular bone tunneling device and wire 130 iscompletely passed through the bone 1000 and tendon or ligament 1002.

In arthroscopic procedures performed using instruments known in the art,the field of view of the camera is generally quite limited, and thesurgeon sees on the screen a magnified view of a small area, normallythe uppermost proximal area of the tendon or ligament. The surgeon doesnot have a wider view and cannot, for example, see in a single view theoperating instrument and the upper portion of the hollow tube or thebone. Reference is now made to FIG. 68, which illustrates an embodimentof the invention in which it incorporates a jig to aid the surgeon inlocating the needle and/or the expected pathway of the needle throughthe bone. FIG. 68A illustrates the distal portion of the instrument withjig 1051 retracted, while FIG. 68B illustrates the same portion of theinstrument with the jig extended. FIG. 68C illustrates the use of thejig. The maximum distance to which the jig can be extended (circled inthe figure) provides the surgeon with the information necessary tounderstand where the end of the instrument is located, where exactly theneedle has entered tendon 1002 and bone 1000, and the overallorientation of the instrument.

FIGS. 68D-68F provides a more clear illustration of jig 1051 withreference to tendon 1002 and bone 1000.

Reference is now made to FIGS. 50-51 illustrating the circular bonetunneling device as described above either manually operated (FIG. 50)or automatically operated (FIG. 51).

According to the motorized embodiment, one motor 1003 is in charge ofthe movement of the needle and the other 1004 in charge of thesupporting element (see FIG. 50)

According to the manual embodiment, one rotating knob 1005 is in chargeof the movement of the needle and the other 1006 in charge of thesupporting element (see FIG. 51).

According to yet another embodiment of the present invention thecircular bone tunneling device comprises a disposable part and reusablepart.

According to this embodiment, the hollow elongate body head 90, is adisposable part to be used once and the handle 12 is a reusable part(see FIG. 52).

Reference is now made to FIGS. 53-54 illustrating another embodiment ofthe present invention in which a retractable sleeve 1007 is provided.

According to this embodiment said retractable sleeve 1007 ischaracterized by having at least two positions: (a) an extended position(see FIG. 53), in which said sleeve 1007 completely encircles needle 32;and, (b) retracted position (see FIG. 54), in which said needle 32partially protrudes out of said retractable sleeve 1007.

The main objective of the use of sleeve 1007 is in the piercing of thetendon. According to this embodiment, the piercing of the tendon isobtained merely by approximating and adjacently bringing the lowelongate body head 90 to the tendon while the sleeve is in the extendedposition and then retracting the sleeve so as to expose the needle andto pierce the tendon.

According to one embodiment of the present invention sleeve 1007 ischaracterized by a spring-like mechanical properties; such that, theactuation of said sleeve 1005 is provided by the compression/stretchingof said spring.

Reference is now made to FIGS. 55-64 which illustrate another embodimentof the present invention in which anchoring means 1009 is being used.Said anchoring means 1009 is adapted to securely fix the tendon to thebone.

FIG. 55 illustrates the needle 32 after the same has tunneled throughbone 1000. At this stage, according to previously disclosed embodiments,the needle is adapted to engage with the support member 54 so as tocatch the suture 130. According to this embodiment, the needle 32engages with anchor 1009, as will be described hereinafter.

Reference is now being made to FIGS. 56-59 which illustrate twoexemplary embodiments of the anchor 1009.

According to one embodiment of the present invention, the anchorcomprises at least one portion 1010 being characterized by cross sectionand/or diameter and/or dimensions substantially greater than thepiercing aperture created in the bone 1000 and the tendon 1002 by needle32. Portion's 1010 main rule is to fixate the anchor 1009 to itsposition and to prevent any movement of the same.

Anchor 1009 additionally comprises at least one second portion 1011 towhich, according to one embodiment, said suture 130 is coupled.

Reference is now being made to FIG. 57 which illustrates the anchor 1009and the suture 130 coupled to the same (namely, to second portion 1011).

Reference is now being made to FIG. 58 which illustrates anotherembodiment of the present invention in which suture 130 is threadedthrough anchor 1009.

According to this embodiment, suture 130 is threaded through secondportion 1011 (and 1010) and then the two ends of the same are folded andabutted against 1010 so as to secure the suture 130 against anchor 1009.

Reference is now being made to FIG. 59 which illustrates anotherembodiment of the present invention in which, in addition to suture 130,a second suture 131 is coupled to anchor 1009.

According to a preferred embodiment of the present invention suture 131is coupled at its two ends to anchor 1009 so as to form a closed loop.Such a loop can be used to interleave additional sutures through thesame.

Reference is now being made to FIGS. 60-61 illustrating theincorporation of such anchor together with the circular bone tunnelingdevice as described above.

FIG. 60 illustrates needle 32 when the same has already engaged withanchor 1009 and captured suture 130. In the Fig. needle 32 is beingretracted out of bone 1000 thereby pulling suture 130 and anchor 1009.

FIG. 61 illustrates anchor 1009, when the same has been abutted againstbone 1000.

FIG. 61 also illustrates interleaving a third suture 133 through theloop formed by the second suture 131.

Reference is now being made to FIGS. 62-64 which illustrate anotherexemplary embodiment of the anchor 1009.

According to this embodiment, the anchor is shaped as a screw anchor ora wall plug.

According to another embodiment, anchor 1009 is provided with a screw1012 so as to provide better fixation to the bone (see FIG. 63).

According to another embodiment, anchor 1009 is provided with a secondsuture 131 being coupled to same. As described above, said second suture131 is used to interleave additional sutures through the same (see FIG.64).

Reference is now made to FIG. 65, which shows an alternativearchitecture for yoke 340 according to some embodiments of theinvention. In these embodiments, the yoke provides asymmetric support tosupport element 54. Rather than being constructed in a generallyfork-like configuration, the yoke comprises only one prong, on one sideonly of head 90. The single prong is connected to support element 54 bya single connector 332. FIG. 65A provides a front view of a typicalnon-limiting configuration in which asymmetrical support is provided.Embodiments in which such asymmetrical support is provided have theadvantage that they leave more room for surgical tool 1001 (e.g.,grasper), thus allowing the use of the invention with a wider variety ofsurgical tools than is possible with symmetrical support. FIG. 65B showsa view from the side opposite that with the prong, showing how surgicaltool 1001 passes through the distal end of the instrument. In theembodiment illustrated in FIG. 65B, the surgical tool is a grasper, butit will be well-understood by those skilled in the art than anyappropriate surgical tool may be used. FIG. 65C presents a top view ofthe distal end of the instrument in the same embodiment, illustratingthe positioning of the surgical tool relative to support element 54 andyoke 340.

According to another embodiment of the present invention, a single useneedle cartridge 5000 is provided. The single use needle cartridge 5000may be specifically selected per every patient and coupled to thereusable circular bone tunneling device 1000 of the present invention.Reference is now made to FIG. 70 illustrating the single use needlecartridge 5000 and the coupling of the same to the circular bonetunneling device 1000 of the present invention.

According to another embodiment of the present invention, the circularbone tunneling device of the present invention can be utilized as asewing machine. Reference is now made to FIGS. 71A-71B illustrating theabove mentioned embodiment.

According to this embodiment, a suture that was threaded into a firsttunnel (illustrated in FIGS. 71A-71B as numerical reference “1”) can becoupled to the circular bone tunneling device's needle, once the samehas tunnel through the tendon and the bone a second tunnel (illustratedin FIGS. 71A-71B as numerical reference “2”).

The coupling of the suture to the circular bone tunneling device'sneedle can be obtained manually by means of e.g., a grasper.

It should be pointed out that the above mentioned first tunnel(illustrated in FIGS. 71A-71B as numerical reference “1”) can beprovided by the circular bone tunneling device of the present invention1000.

Another issue which is of extreme importance is the ability to stabilizeand fixate the device of the present invention in a predeterminedposition and orientation relative to the bone. The same is provided by“grabbing” and firmly holding the bone at two different points along anarc and then stabilizing the device relative to the bone by astabilizing element (that reduces the movement, degrees of freedom). Thestabilizing element reduces the device's degrees of freedom fixating thedevice to the bone at a third contact point such that movement isminimized and the forces applied to the needle will be facilitated to beable to drive into the bone and further inadvertent movement by thephysician due to hand movements will not affect the position of thedevice.

It is to be understood that unintentional movement of the needle (or theentire device) can lead the needle to penetrate the bone at the wrongangle and/or in the wrong position; and therefore cause excess damage tothe bone.

Furthermore, incorrect angular penetration may well lead to a poorclinical outcome.

Such provision of angular fixation ensures that the device will bemaintained in a constant position and orientation relative to the boneso as to enable the needle to penetrate with the proper angularorientation and at the proper position relative to the bone and withoutany undesired movements (namely angular movements) of the device.

Reference is now made to FIGS. 72-78 illustrating the above mentionedembodiment of the present invention. According to this embodiment, astabilizing element 7200 is provided.

According to this embodiment, the stabilizing element 7200 is adapted tobe in physical contact with said bone so as to fixate the orientationand position of the circular bone tunneling device relative to saidbone.

According to another embodiment of the present invention the stabilizingelement 7200 is characterized by at least one extended configuration(see FIGS. 72-73), in which said stabilizing element 7200 extends out ofthe hollow elongate body 7300, and at least one retracted configuration(see FIG. 74), in which said stabilizing element 7200 is encased withinthe hollow elongate body 7300. It is within the provision of the presentinvention wherein said stabilizing element 7200 is reconfigurable fromsaid extended configuration to said retracted configuration and viceversa.

According to one embodiment of the present invention saidreconfiguration of said stabilizing element from said extendedconfiguration to said retracted configuration and vice versa is providedby reciprocally moving said stabilizing element along the mainlongitudinal axis of the circular bone tunneling device.

According to one embodiment of the present invention the stabilizingelement 7200 is pivotally coupled, at a pivot point, to the distal endof the hollow elongate body 7300 at a pivot point. According to thisembodiment, said reconfiguration of said stabilizing element from saidextended configuration to said retracted configuration and vice versa isprovided by radially and pivotably rotating the stabilizing element 7200around said pivot point.

According to one embodiment of the present invention, the stabilizingelement 7200 is merely in physical contact with the bone 1000. Saidphysical contact provides said fixation of the device relative to saidbone.

According to another embodiment of the present invention, thestabilizing element 7200 is anchored within the bone 1000 (see FIGS.75-76, for example).

Reference is now made to FIGS. 75-76 which illustrates the stabilizingelement 7200 in the extended configuration and the support element 54 inthe extended configuration. In this position the device is fixated inits orientation to the bone.

Reference is now made to FIGS. 77-78 providing a closer look at thestabilizing element 7200.

As can be seen in the Figs., the stabilizing element 7200 ischaracterized by a distal end 7201 and a proximal end 7202.

According to said embodiment the distal end 7201 comprises a flange 7203and a tip 7204. Tip 7204 is adapted to penetrate the bone 1000 and toanchor the stabilizing element within the same.

Flange 7203 adapted to limit the penetration of the stabilizing element7200 into the bone. In other words, the stabilizing element 7200 isadapted to prevent the insertion of the proximal end 7202 of thestabilizing element 7200 into said bone 1000 such that only said tip7204 is anchored within said bone 1000.

According to another embodiment of the present invention, the tip 7204of the stabilizing element 7200 may have different shapes. One exampleis a nail-like tip (see FIG. 77); while another embodiment is ascrew-like tip (see FIG. 78). Of course said shapes can be altered andare not limited to the ones disclosed above.

Reference is now made to FIGS. 79-85 illustrating another embodiment ofthe stabilizing element 7200.

As mentioned above, the stabilizing element 7200 is introduced throughthe hollow elongate body 7300 of the device and adapted to reciprocallymove along the main longitudinal axis of the hollow elongate body 7300of the device.

According to another embodiment, the stabilizing element 7200 comprisesat least one marker 7210 on the same (see FIG. 80). Preferably saidmarker 7210 is engraved on the stabilizing element 7200.

Marker 7210 is adapted to indicate the contact point of the stabilizingelement 7200 with the bone 1000 (i.e., that the stabilizing element 7200has come into physical contact with the bone, as the same is furtheradvanced through the hollow elongate body 7300 of the device). In otherwords, the marker 7210 verifies/informs the user as for the currentposition of the stabilizing element 7200 with respect to the bone.

According to another embodiment, a second indicator 7211 is provided,see FIG. 81.

Indicator 7211 is provided with a ruler or a yardstick having numericalreferences 7211 a staring from 0 to at least 5. Said numericalreferences 7211 a are adapted to indicate the user how far thestabilizing element 7200 has penetrated the bone 1000. For example, ifthe second indicator 7211 indicates 0, thus the stabilizing element 7200has not penetrated the bone at all but is in contact with the same. Ifthe second indicator 7211 indicates 5, thus the stabilizing element 7200has penetrated 5 mm into the bone.

The indication provided by the second indicator 7211 is provided by theintegration and the intersection between the engraved marker 7210 andthe numerical references 7211 a on the second indicator 7211.

FIG. 82 illustrates the stabilizing element 7200 when the same is inphysical contact with the bone 1000. i.e., when indicator 7211 indicates‘0’.

When indicator 7211 indicates ‘5’ (see FIG. 83), the stabilizing element7200 has penetrated the bone 1000 5 mm (see FIG. 84).

Reference is now made to FIG. 85 illustrating yet another embodiment ofthe present invention. According to this embodiment, the device of thepresent invention further comprises a locking mechanism 7213 adapted tolock the stabilizing element 7200 is position.

In light of the above disclosure, the circular bone tunneling device ofthe present invention comprises inherently each of the followingadvantages:

(a) the circular bone tunneling device of the present inventionpenetrates tendon and bone in a single step. The needle creates a tunnelthrough the tendon and the bone in said single step.

(b) the circular bone tunneling device of the present invention has aunique needle that penetrates the tendon, the bone, automaticallycatches the suture and withdraws the same all the way back. In otherwords, there is only one step for both the tunneling and the suturepassage.

(c) With the circular bone tunneling device of the present invention,the physician penetrates from one entry point to second exit pointforming a circular tunnel (one tunnel only).

(d) The circular bone tunneling device of the present invention has aspecially adapted cartridge that threads the suture passed through thebone and the tendon by actuating the integral elements of the devicedesigned to thread and feed the suture into the tunnel and through theligament. This is in sharp contrast to commonly used devices which arenot adapted to thread the suture but rather “a temporary suture” or aguide suture which is used to shuttle the final sutures through thetunnel.

(e) The circular bone tunneling device of the present invention isadapted to penetrate varying diameter bones and bone structures and cancreate tunnels of varying lengths specifically adapted to the variousgeometries of different bones in different locations and sizes. Due toits unique extendable and retractable support element (that can beopened to different sizes), the tunnel length is varied and the deviceis adapted for different bone size or different clinical needs.

(f) The circular bone tunneling device of the present invention has aworking channel throughout which one can pass various working toolsrequired (e.g. a Cartridge, Grasper, Manipulator a JIG or any otherdevice).

(g) The circular bone tunneling device of the present invention hasexternal indicators that enable the surgeon to understand where theneedle and the support arm are located at any given time along theprocedure.

(h) The circular bone tunneling device of the present invention may befixated in its position relatively to the bone throughout at least aportion of the procedure (by means of the stabilizing element).Alternatively the circular bone tunneling device may be fixated in itsposition relatively to the bone throughout the entire procedure. Ineither case, such provision ensures that the device will be maintainedat a constant position relatively to the bone so as to enable the needleto penetrate the bone without any undesired movements (e.g., angularmovements) of the same.

It should be emphasized that each of the above can be carried outindependently or any combination can be used in the circular bonetunneling device.

In the foregoing description, embodiments of the invention, includingpreferred embodiments, have been presented for the purpose ofillustration and description. They are not intended to be exhaustive orto limit the invention to the precise form disclosed. Obviousmodifications or variations are possible in light of the aboveteachings. The embodiments were chosen and described to provide the bestillustration of the principals of the invention and its practicalapplication, and to enable one of ordinary skill in the art to utilizethe invention in various embodiments and with various modifications asare suited to the particular use contemplated. All such modificationsand variations are within the scope of the invention as determined bythe appended claims when interpreted in accordance with the breadth theyare fairly, legally, and equitably entitled.

We claim:
 1. A bone tunneling device, for use in arthroscopic surgery,comprising: a hollow elongate body including a hollow elongate bodyhead, said hollow elongate body head including a surgical needle adaptedto tunnel through a bone, thereby forming a transosseous tunnel throughsaid bone; and a suture cartridge including a suture located at apredetermined location of said suture cartridge; said surgical needleincluding a suture engagement portion, adjacent a distal end thereof,adapted to engage said suture and to catch said suture from saidpredetermined location after said surgical needle has formed saidtransosseous tunnel, and, upon retraction of said surgical needlethrough said transosseous tunnel, to draw said suture through saidtransosseous tunnel.
 2. The circular bone tunneling device according toclaim 1, further comprising a shaft including an inner elongated hollowtube.
 3. The circular bone tunneling device according to claim 1,wherein said surgical needle is a rigid surgical needle.
 4. The circularbone tunneling device according to claim 1, further comprising a needlecontrol adapted to advance and retract said surgical needle through saidbone.
 5. The circular bone tunneling device according to claim 1 andwherein said suture cartridge includes an inner body.
 6. The circularbone tunneling device according to claim 5 and wherein said inner bodyis utilizable as a working channel.
 7. A method for tunneling through abone during arthroscopic surgery, said method comprising: providing abone tunneling device including a surgical needle adapted to tunnelthrough a bone and a suture cartridge, said surgical needle including asuture engagement portion, adjacent a distal end thereof, said suturecartridge including a suture located at a predetermined location of saidsuture cartridge; forming a transosseous tunnel through said bone bymoving said needle forwardly through said bone; thereafter, engagingsaid suture with said suture engagement portion of said needle andcatching said suture from said predetermined location; and thereafter,retracting said surgical needle through said transosseous tunnel,thereby drawing said suture through said transosseous tunnel.